Rheumatoid Arthritis
Conditions
Brief summary
This open-label study will evaluate the efficacy and safety of tocilizumab as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) in participants with active rheumatoid arthritis (RA) and an inadequate response to current non-biologic DMARD therapy or the first anti-tumour necrosis factor (anti-TNF) agent. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously once a week for 52 weeks.
Interventions
DRUGTocilizumab
Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 52 weeks.
DRUGDMARDs
Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study. The study protocol does not specify any particular therapy.
Stable oral corticosteroids doses (≤10 mg/day prednisone or equivalent) are allowed. The study protocol does not specify any additional detail on types of oral corticosteroids.
DRUGMethotrexate
Methotrexate per investigator's discretion.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria * Participants who have an inadequate response to current non-biologic DMARD therapy or the first anti-TNF agent (in monotherapy or in combination with MTX or other non-biologic DMARDs). Inadequate response to anti-TNF treatment is defined as DAS28 score improvement of less than 1.2 or participants achieving a DAS28 score improvement of 1.2 but not achieving low disease activity (current DAS28-ESR above 3.2) according to a treat-to-target strategy and have not been previously exposed to treatment with tocilizumab. Inadequate response to non-biologic DMARD therapy will be assessed according to local guidelines and the participants will need to be eligible for biologic therapy according to local guidelines * Oral corticosteroids (≤10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to recommended dose) are permitted if on stable dose regimen for greater than or equal to \[≥\] 4 weeks prior to baseline * Permitted non-biologic DMARDs are allowed if on stable dose for at least 4 weeks prior to baseline * Receiving treatment on an outpatient basis, not including tocilizumab * Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol during the study and for at least 3 months following the last dose of tocilizumab
Exclusion criteria
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline * Rheumatic autoimmune disease other than RA * Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis * Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16 * Prior history of or current inflammatory joint disease other than RA * Exposure to tocilizumab either intravenous or SC at any time prior to baseline * Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening * Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline * History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies * Known active current or history of recurrent infections * Major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening * Active tuberculosis (TB) requiring treatment within the previous 3 years * Positive for hepatitis B or hepatitis C virus infection * Primary or secondary immunodeficiency (history of or currently active) * Pregnant or lactating women * Inadequate hematologic, renal or liver function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 2 | Baseline, Week 2 | DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR; millimeters per hour \[mm/hour\]), and patient's global assessment of disease activity (measured on a 0 to 100 mm Visual Analog Scale \[VAS\] where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR greater than or equal to (≥) 2.6 to less than or equal to (≤) 3.2 implied low disease activity, greater than (\>) 3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and less than (\<) 2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Week 4 | Baseline, Week 4 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Week 8 | Baseline, Week 8 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Week 12 | Baseline, Week 12 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Week 16 | Baseline, Week 16 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Week 20 | Baseline, Week 20 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Week 24 | Baseline, Week 24 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Week 28 | Baseline, Week 28 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Week 32 | Baseline, Week 32 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Week 36 | Baseline, Week 36 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Week 40 | Baseline, Week 40 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Week 44 | Baseline, Week 44 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Week 48 | Baseline, Week 48 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Week 52 | Baseline, Week 52 | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
| Change From Baseline in DAS28-ESR at Early Withdrawal | Baseline, early withdrawal (up to Week 52) | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain VAS Score | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | This assessment represents the participant's assessment of his/her current level of pain on a 100 mm horizontal VAS where 0 mm= no pain to 100 mm= unbearable pain. |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | The FACIT-F score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). |
| Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in TJC (68 joints) and SJC (66 joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, averaged to 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either C-reactive protein \[CRP\] or ESR). |
| Number of Participants With Anti-Tocilizumab Antibodies | Baseline, Weeks 12 and 24, at early withdrawal (up to Week 52), and follow-up visit (8 weeks after last dose of tocilizumab, up to 60 weeks) | — |
| Serum Levels of Tocilizumab | Baseline, Weeks 12 and 24, at early withdrawal (up to Week 52), and follow-up visit (8 weeks after last dose of tocilizumab, up to 60 weeks) | — |
| Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) | Baseline, Weeks 12 and 24, at early withdrawal (up to Week 52), and follow-up visit (8 weeks after last dose of tocilizumab, up to 60 weeks) | — |
| Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | A diary card was provided to participants to record home injections. Participants were asked to return all empty drug supply boxes, unused pre-filled syringe, and diary cards to the clinic at each visit as a measure of drug accountability and participant compliance. A participant was considered compliant if the participant correctly administered all scheduled doses of SC tocilizumab during the assessment period. |
| Number of Participants Achieving an ACR50 Response | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | A participant had an ACR50 response if there was at least a 50% improvement, ie, reduction from Baseline, in TJC (68 joints) and SJC (66 joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, averaged to 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). |
| Number of Participants Achieving an ACR70 Response | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | A participant had an ACR70 response if there was at least a 70% improvement, ie, reduction from Baseline, in TJC (68 joints) and SJC (66 joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, averaged to 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). |
| Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). DAS28-ESR scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. The DAS28-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline \>1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline \>1.2 with a DAS28 score \>3.2 or a change from baseline \>0.6 to ≤1.2 with a DAS28 score ≤5.1. Participants with change from baseline \>0.6 to ≤1.2 with a DAS28 score \>5.1, or any score with change from baseline ≤0.6, were assessed as non-responders. |
| Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician global assessment of disease activity assessed on 0-10 centimeter (cm) VAS (0 cm= no disease activity and 10 cm= worst disease activity), and CRP in milligrams per liter (mg/L). SDAI total score = 0-86. SDAI ≤3.3 indicates clinical remission, \>3.3 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high (or severe) disease activity. |
| Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician's global assessment of disease activity assessed on 0-10 cm VAS (0 cm= no disease activity and 10 cm= worst disease activity). CDAI total score = 0-76. CDAI ≤2.8 indicates clinical remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high (or severe) disease activity. |
| Percent Change From Baseline in Total TJC on 68 Joints at Week 52 | Baseline, Week 52 | Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 68. A reduction in number of tender joints compared to baseline indicates improvement. The outcome is reported as the percent change from baseline to end of treatment (52 weeks). |
| Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement. |
| Percent Change From Baseline in Total SJC on 66 Joints at Week 52 | Baseline, Week 52 | Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 66. A reduction in number of swollen joints compared to baseline indicates improvement. The outcome is reported as the percent change from baseline to end of treatment (52 weeks). |
| Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement. |
| Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity. |
| Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR \<2.6 implied clinical remission. |
| Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, at early withdrawal (up to Week 52), follow-up Week 4 (up to Week 56), and follow-up Week 8 (up to Week 60) | Results are reported for number of participants who had non-biologic DMARD/corticosteroid dose reductions and/or discontinuation by reasons for dose reductions or discontinuation (safety reasons, discomfort, lack of efficacy, other reasons, and unknown reasons). Participants may be included under more than one reason. |
| Percentage of Methotrexate Adherence as Assessed by Methotrexate Adherence Questionnaire | Baseline, Weeks 12, 24, 36, 52, and at early withdrawal (up to Week 52) | Methotrexate adherence was determined from responses to the question 'Over the last 3 months you were prescribed 12 doses of methotrexate, how many (approximately) have you taken?' Adherence (%) was calculated as: (Approximate number of doses taken/12)\*100. |
| Patient Global Assessment of Disease Activity VAS Score | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52) | Patient global assessment of disease activity was measured on a 0 to 100 mm horizontal VAS where 0 mm=no disease activity and 100 mm=maximum disease activity. |
Countries
United Kingdom
Participant flow
Pre-assignment details
A total of 162 participants were enrolled. One participant who did not receive a dose of tocilizumab was excluded from the full analysis set (FAS) and the results are reported for 161 participants.
Participants by arm
| Arm | Count |
|---|---|
| Tocilizumab Monotherapy Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy for 52 weeks. | 21 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs Participants received a weekly SC injection of tocilizumab 162 mg in combination with methotrexate or other non-biologic DMARDs for 52 weeks. | 140 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Other | 11 | 66 |
| Overall Study | Participant/legal guardian decision | 1 | 3 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Tocilizumab Monotherapy | Tocilizumab in Combination With Methotrexate or Other DMARDs | Total |
|---|---|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 13.63 | 55.3 years STANDARD_DEVIATION 10.76 | 55.1 years STANDARD_DEVIATION 11.14 |
| Sex: Female, Male Female | 16 Participants | 104 Participants | 120 Participants |
| Sex: Female, Male Male | 5 Participants | 36 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 21 | 135 / 140 |
| serious Total, serious adverse events | 3 / 21 | 7 / 140 |
Outcome results
Primary
Change From Baseline in DAS28-ESR at Early Withdrawal
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, early withdrawal (up to Week 52)
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Early Withdrawal | -2.88 units on a scale | Standard Deviation 1.236 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Early Withdrawal | -1.63 units on a scale | Standard Deviation 1.48 |
Primary
Change From Baseline in DAS28-ESR at Week 12
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, Week 12
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Week 12 | -2.33 units on a scale | Standard Deviation 1.522 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Week 12 | -2.99 units on a scale | Standard Deviation 1.51 |
Primary
Change From Baseline in DAS28-ESR at Week 16
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, Week 16
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Week 16 | -2.93 units on a scale | Standard Deviation 1.218 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Week 16 | -3.07 units on a scale | Standard Deviation 1.532 |
Primary
Change From Baseline in DAS28-ESR at Week 20
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, Week 20
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Week 20 | -3.17 units on a scale | Standard Deviation 1.346 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Week 20 | -3.13 units on a scale | Standard Deviation 1.525 |
Primary
Change From Baseline in DAS28-ESR at Week 24
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, Week 24
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Week 24 | -3.28 units on a scale | Standard Deviation 1.379 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Week 24 | -3.33 units on a scale | Standard Deviation 1.47 |
Primary
Change From Baseline in DAS28-ESR at Week 28
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, Week 28
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Week 28 | -3.54 units on a scale | Standard Deviation 1.26 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Week 28 | -3.32 units on a scale | Standard Deviation 1.552 |
Primary
Change From Baseline in DAS28-ESR at Week 32
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, Week 32
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Week 32 | -3.19 units on a scale | Standard Deviation 1.418 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Week 32 | -3.54 units on a scale | Standard Deviation 1.448 |
Primary
Change From Baseline in DAS28-ESR at Week 36
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, Week 36
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Week 36 | -3.57 units on a scale | Standard Deviation 1.358 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Week 36 | -3.55 units on a scale | Standard Deviation 1.589 |
Primary
Change From Baseline in DAS28-ESR at Week 4
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, Week 4
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Week 4 | -1.86 units on a scale | Standard Deviation 1.016 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Week 4 | -2.11 units on a scale | Standard Deviation 1.215 |
Primary
Change From Baseline in DAS28-ESR at Week 40
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, Week 40
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Week 40 | -3.82 units on a scale | Standard Deviation 1.143 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Week 40 | -3.64 units on a scale | Standard Deviation 1.524 |
Primary
Change From Baseline in DAS28-ESR at Week 44
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, Week 44
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Week 44 | -3.61 units on a scale | Standard Deviation 1.325 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Week 44 | -3.65 units on a scale | Standard Deviation 1.574 |
Primary
Change From Baseline in DAS28-ESR at Week 48
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, Week 48
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Week 48 | -3.54 units on a scale | Standard Deviation 1.146 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Week 48 | -3.65 units on a scale | Standard Deviation 1.552 |
Primary
Change From Baseline in DAS28-ESR at Week 52
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, Week 52
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Week 52 | -3.75 units on a scale | Standard Deviation 1.361 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Week 52 | -3.67 units on a scale | Standard Deviation 1.592 |
Primary
Change From Baseline in DAS28-ESR at Week 8
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, \>3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and \<2.6 implied clinical remission.
Time frame: Baseline, Week 8
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in DAS28-ESR at Week 8 | -2.42 units on a scale | Standard Deviation 1.352 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in DAS28-ESR at Week 8 | -2.62 units on a scale | Standard Deviation 1.482 |
Primary
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 2
DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR; millimeters per hour \[mm/hour\]), and patient's global assessment of disease activity (measured on a 0 to 100 mm Visual Analog Scale \[VAS\] where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR greater than or equal to (≥) 2.6 to less than or equal to (≤) 3.2 implied low disease activity, greater than (\>) 3.2 to ≤5.1 implied moderate disease activity, \>5.1 implied high/severe disease, and less than (\<) 2.6 implied clinical remission.
Time frame: Baseline, Week 2
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 2 | Baseline | 5.52 units on a scale | Standard Deviation 1.014 |
| Tocilizumab Monotherapy | Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 2 | Change at Week 2 | -1.41 units on a scale | Standard Deviation 0.994 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 2 | Baseline | 5.53 units on a scale | Standard Deviation 1.257 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 2 | Change at Week 2 | -1.22 units on a scale | Standard Deviation 1.131 |
Secondary
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal
The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician's global assessment of disease activity assessed on 0-10 cm VAS (0 cm= no disease activity and 10 cm= worst disease activity). CDAI total score = 0-76. CDAI ≤2.8 indicates clinical remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high (or severe) disease activity.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 2 | -8.35 units on a scale | Standard Deviation 10.433 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Baseline | 29.69 units on a scale | Standard Deviation 11.209 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 4 | -11.87 units on a scale | Standard Deviation 10.062 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 8 | -17.74 units on a scale | Standard Deviation 12.289 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 12 | -15.39 units on a scale | Standard Deviation 14.216 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 16 | -20.70 units on a scale | Standard Deviation 11.694 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 20 | -22.19 units on a scale | Standard Deviation 13.545 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 24 | -22.88 units on a scale | Standard Deviation 12.72 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 28 | -23.43 units on a scale | Standard Deviation 11.573 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 32 | -21.55 units on a scale | Standard Deviation 12.019 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 36 | -24.86 units on a scale | Standard Deviation 11.854 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 40 | -25.74 units on a scale | Standard Deviation 12.488 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 44 | -25.42 units on a scale | Standard Deviation 11.971 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 48 | -25.36 units on a scale | Standard Deviation 12.718 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 52 | -25.48 units on a scale | Standard Deviation 13.049 |
| Tocilizumab Monotherapy | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at early withdrawal | -17.78 units on a scale | Standard Deviation 14.667 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at early withdrawal | -8.68 units on a scale | Standard Deviation 11.909 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 28 | -21.48 units on a scale | Standard Deviation 11.585 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Baseline | 30.88 units on a scale | Standard Deviation 10.953 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 2 | -5.16 units on a scale | Standard Deviation 9.323 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 44 | -24.42 units on a scale | Standard Deviation 11.186 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 4 | -12.26 units on a scale | Standard Deviation 10.137 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 32 | -23.20 units on a scale | Standard Deviation 10.842 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 8 | -15.63 units on a scale | Standard Deviation 11.873 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 52 | -24.42 units on a scale | Standard Deviation 12.599 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 12 | -18.66 units on a scale | Standard Deviation 11.895 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 36 | -23.10 units on a scale | Standard Deviation 11.263 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 16 | -19.51 units on a scale | Standard Deviation 11.124 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 48 | -24.59 units on a scale | Standard Deviation 10.645 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 20 | -19.23 units on a scale | Standard Deviation 11.433 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 40 | -24.01 units on a scale | Standard Deviation 11.282 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 24 | -21.96 units on a scale | Standard Deviation 11.825 |
Secondary
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal
The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician global assessment of disease activity assessed on 0-10 centimeter (cm) VAS (0 cm= no disease activity and 10 cm= worst disease activity), and CRP in milligrams per liter (mg/L). SDAI total score = 0-86. SDAI ≤3.3 indicates clinical remission, \>3.3 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high (or severe) disease activity.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at early withdrawal | -18.94 units on a scale | Standard Deviation 14.681 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 32 | -22.98 units on a scale | Standard Deviation 12.85 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 48 | -26.83 units on a scale | Standard Deviation 13.615 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Baseline | 31.23 units on a scale | Standard Deviation 11.892 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 2 | -9.80 units on a scale | Standard Deviation 10.406 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 4 | -12.64 units on a scale | Standard Deviation 10.502 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 12 | -14.65 units on a scale | Standard Deviation 15.003 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 16 | -19.48 units on a scale | Standard Deviation 9.649 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 20 | -23.67 units on a scale | Standard Deviation 14.015 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 24 | -24.31 units on a scale | Standard Deviation 13.469 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 28 | -24.87 units on a scale | Standard Deviation 12.554 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 36 | -26.32 units on a scale | Standard Deviation 12.795 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 40 | -27.29 units on a scale | Standard Deviation 13.28 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 44 | -27.71 units on a scale | Standard Deviation 12.851 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 52 | -27.45 units on a scale | Standard Deviation 14.351 |
| Tocilizumab Monotherapy | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 8 | -19.75 units on a scale | Standard Deviation 12.978 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 48 | -26.13 units on a scale | Standard Deviation 11.189 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 12 | -20.26 units on a scale | Standard Deviation 12.739 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 24 | -23.48 units on a scale | Standard Deviation 12.417 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 20 | -20.50 units on a scale | Standard Deviation 11.63 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 40 | -25.46 units on a scale | Standard Deviation 12.21 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at early withdrawal | -9.45 units on a scale | Standard Deviation 12.533 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 52 | -26.15 units on a scale | Standard Deviation 12.791 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Baseline | 32.33 units on a scale | Standard Deviation 11.62 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 28 | -23.26 units on a scale | Standard Deviation 12.418 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 2 | -6.94 units on a scale | Standard Deviation 9.71 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 32 | -24.94 units on a scale | Standard Deviation 11.399 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 4 | -13.92 units on a scale | Standard Deviation 10.666 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 8 | -17.21 units on a scale | Standard Deviation 12.9 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 44 | -26.08 units on a scale | Standard Deviation 11.835 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 36 | -24.65 units on a scale | Standard Deviation 11.268 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 16 | -21.16 units on a scale | Standard Deviation 11.945 |
Secondary
Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal
Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Baseline | 7.0 swollen joints | Standard Deviation 4.64 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 2 | -2.5 swollen joints | Standard Deviation 4.31 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 4 | -4.2 swollen joints | Standard Deviation 3.79 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 8 | -4.8 swollen joints | Standard Deviation 4.21 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 12 | -4.2 swollen joints | Standard Deviation 4.37 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 16 | -5.3 swollen joints | Standard Deviation 4.67 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 20 | -5.6 swollen joints | Standard Deviation 5.08 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 24 | -5.9 swollen joints | Standard Deviation 5.12 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 28 | -6.4 swollen joints | Standard Deviation 4.9 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 32 | -5.4 swollen joints | Standard Deviation 5.1 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 36 | -6.5 swollen joints | Standard Deviation 4.57 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 40 | -6.6 swollen joints | Standard Deviation 5.12 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 44 | -6.6 swollen joints | Standard Deviation 5.28 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 48 | -6.4 swollen joints | Standard Deviation 4.83 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 52 | -6.3 swollen joints | Standard Deviation 4.81 |
| Tocilizumab Monotherapy | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at early withdrawal | -5.8 swollen joints | Standard Deviation 5.59 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at early withdrawal | -1.7 swollen joints | Standard Deviation 4.43 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Baseline | 5.6 swollen joints | Standard Deviation 4.43 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 28 | -4.4 swollen joints | Standard Deviation 4.63 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 2 | -0.8 swollen joints | Standard Deviation 3.95 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 44 | -5.2 swollen joints | Standard Deviation 4.71 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 4 | -2.5 swollen joints | Standard Deviation 3.81 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 32 | -4.8 swollen joints | Standard Deviation 4.37 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 8 | -3.2 swollen joints | Standard Deviation 4.4 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 52 | -5.1 swollen joints | Standard Deviation 4.51 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 12 | -3.8 swollen joints | Standard Deviation 4.36 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 36 | -4.9 swollen joints | Standard Deviation 4.41 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 16 | -3.9 swollen joints | Standard Deviation 4.41 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 48 | -5.0 swollen joints | Standard Deviation 4.48 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 20 | -4.2 swollen joints | Standard Deviation 4.6 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 40 | -5.0 swollen joints | Standard Deviation 4.82 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 24 | -4.7 swollen joints | Standard Deviation 4.21 |
Secondary
Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal
Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 40 | -10.1 tender joints | Standard Deviation 6.64 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 28 | -8.7 tender joints | Standard Deviation 6.26 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 2 | -3.4 tender joints | Standard Deviation 5.62 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 32 | -7.6 tender joints | Standard Deviation 6.64 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 12 | -6.0 tender joints | Standard Deviation 6.71 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 36 | -9.4 tender joints | Standard Deviation 6.25 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Baseline | 10.4 tender joints | Standard Deviation 6.46 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 16 | -7.9 tender joints | Standard Deviation 6.35 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 44 | -9.7 tender joints | Standard Deviation 6.46 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 4 | -3.9 tender joints | Standard Deviation 5.8 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 48 | -9.6 tender joints | Standard Deviation 6.36 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 20 | -8.5 tender joints | Standard Deviation 6.59 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 52 | -9.4 tender joints | Standard Deviation 7.15 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 24 | -8.3 tender joints | Standard Deviation 7.41 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at early withdrawal | -7.0 tender joints | Standard Deviation 6.24 |
| Tocilizumab Monotherapy | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 8 | -6.6 tender joints | Standard Deviation 6.41 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at early withdrawal | -3.3 tender joints | Standard Deviation 7.46 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 20 | -8.3 tender joints | Standard Deviation 7.09 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Baseline | 12.9 tender joints | Standard Deviation 7.06 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 2 | -2.4 tender joints | Standard Deviation 5.63 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 4 | -5.4 tender joints | Standard Deviation 6.14 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 8 | -6.4 tender joints | Standard Deviation 6.94 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 12 | -8.0 tender joints | Standard Deviation 7.35 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 16 | -8.2 tender joints | Standard Deviation 7.05 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 24 | -9.3 tender joints | Standard Deviation 7.53 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 28 | -9.2 tender joints | Standard Deviation 7.04 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 32 | -10.1 tender joints | Standard Deviation 6.76 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 36 | -9.7 tender joints | Standard Deviation 7.23 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 40 | -10.3 tender joints | Standard Deviation 6.74 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 44 | -10.4 tender joints | Standard Deviation 6.63 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 48 | -10.5 tender joints | Standard Deviation 6.7 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal | Change at Week 52 | -10.4 tender joints | Standard Deviation 8.01 |
Secondary
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
The FACIT-F score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score).
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 28 | 32.9 units on a scale | Standard Deviation 12.06 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Baseline | 18.4 units on a scale | Standard Deviation 11.14 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 32 | 34.1 units on a scale | Standard Deviation 12.68 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 12 | 28.4 units on a scale | Standard Deviation 11.71 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 36 | 30.3 units on a scale | Standard Deviation 13.62 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 16 | 31.3 units on a scale | Standard Deviation 13.8 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 40 | 31.7 units on a scale | Standard Deviation 12.87 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 4 | 25.1 units on a scale | Standard Deviation 12.28 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 44 | 31.0 units on a scale | Standard Deviation 14.02 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 20 | 33.2 units on a scale | Standard Deviation 13.57 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 48 | 31.6 units on a scale | Standard Deviation 14.63 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 2 | 23.1 units on a scale | Standard Deviation 12.37 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 52 | 33.4 units on a scale | Standard Deviation 14.17 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 24 | 33.8 units on a scale | Standard Deviation 15.28 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Early withdrawal | 31.3 units on a scale | Standard Deviation 2.63 |
| Tocilizumab Monotherapy | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 8 | 30.2 units on a scale | Standard Deviation 11.58 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Early withdrawal | 24.5 units on a scale | Standard Deviation 12.08 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Baseline | 24.3 units on a scale | Standard Deviation 11.55 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 2 | 27.9 units on a scale | Standard Deviation 11.03 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 4 | 30.7 units on a scale | Standard Deviation 12.1 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 8 | 32.8 units on a scale | Standard Deviation 11.91 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 16 | 34.0 units on a scale | Standard Deviation 12.53 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 20 | 34.1 units on a scale | Standard Deviation 12.05 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 24 | 35.3 units on a scale | Standard Deviation 10.98 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 28 | 35.5 units on a scale | Standard Deviation 11.59 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 32 | 36.2 units on a scale | Standard Deviation 11.32 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 36 | 36.8 units on a scale | Standard Deviation 11.48 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 40 | 37.1 units on a scale | Standard Deviation 11.69 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 44 | 37.2 units on a scale | Standard Deviation 11.75 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 48 | 37.9 units on a scale | Standard Deviation 11.73 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 52 | 38.1 units on a scale | Standard Deviation 11.16 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Week 12 | 33.7 units on a scale | Standard Deviation 11.85 |
Secondary
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 | 1.508 units on a scale | Standard Deviation 0.7597 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 28 | 1.330 units on a scale | Standard Deviation 0.9412 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 44 | 1.442 units on a scale | Standard Deviation 0.9392 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 | 1.558 units on a scale | Standard Deviation 0.7319 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 32 | 1.351 units on a scale | Standard Deviation 0.8816 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 | 1.488 units on a scale | Standard Deviation 0.9304 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 36 | 1.432 units on a scale | Standard Deviation 0.9048 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Early withdrawal | 1.252 units on a scale | Standard Deviation 1.1232 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 40 | 1.479 units on a scale | Standard Deviation 0.8975 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 16 | 1.351 units on a scale | Standard Deviation 0.9586 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 | 1.616 units on a scale | Standard Deviation 0.772 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 48 | 1.361 units on a scale | Standard Deviation 0.9685 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 20 | 1.409 units on a scale | Standard Deviation 0.9071 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 52 | 1.338 units on a scale | Standard Deviation 0.9796 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline | 1.806 units on a scale | Standard Deviation 0.5551 |
| Tocilizumab Monotherapy | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 24 | 1.330 units on a scale | Standard Deviation 0.8379 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Early withdrawal | 1.756 units on a scale | Standard Deviation 0.782 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 | 1.659 units on a scale | Standard Deviation 0.621 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 | 1.546 units on a scale | Standard Deviation 0.7351 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 | 1.404 units on a scale | Standard Deviation 0.8115 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 | 1.333 units on a scale | Standard Deviation 0.8272 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 16 | 1.312 units on a scale | Standard Deviation 0.8621 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 20 | 1.318 units on a scale | Standard Deviation 0.8608 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 24 | 1.261 units on a scale | Standard Deviation 0.8915 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 28 | 1.221 units on a scale | Standard Deviation 0.873 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 32 | 1.232 units on a scale | Standard Deviation 0.887 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 36 | 1.170 units on a scale | Standard Deviation 0.8757 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 40 | 1.199 units on a scale | Standard Deviation 0.8908 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 44 | 1.130 units on a scale | Standard Deviation 0.9206 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 48 | 1.114 units on a scale | Standard Deviation 0.8815 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 52 | 1.154 units on a scale | Standard Deviation 0.9187 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline | 1.738 units on a scale | Standard Deviation 0.6406 |
Secondary
Number of Participants Achieving an ACR50 Response
A participant had an ACR50 response if there was at least a 50% improvement, ie, reduction from Baseline, in TJC (68 joints) and SJC (66 joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, averaged to 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR).
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 16 | 7 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 32 | 8 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 4 | 3 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 36 | 9 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 20 | 9 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 40 | 9 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 12 | 8 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 44 | 10 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 24 | 9 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 48 | 11 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 8 | 6 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 52 | 8 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 28 | 13 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Early withdrawal | 2 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR50 Response | Week 2 | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Early withdrawal | 4 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 2 | 5 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 4 | 20 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 8 | 43 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 12 | 54 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 16 | 62 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 20 | 61 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 24 | 64 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 28 | 68 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 32 | 69 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 36 | 74 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 40 | 71 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 44 | 72 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 48 | 73 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR50 Response | Week 52 | 73 participants |
Secondary
Number of Participants Achieving an ACR70 Response
A participant had an ACR70 response if there was at least a 70% improvement, ie, reduction from Baseline, in TJC (68 joints) and SJC (66 joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, averaged to 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR).
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 12 | 3 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 32 | 6 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 16 | 3 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 36 | 7 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 2 | 0 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 40 | 8 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 20 | 7 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 44 | 6 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 8 | 4 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 48 | 8 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 24 | 5 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 52 | 7 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 4 | 1 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Early withdrawal | 2 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an ACR70 Response | Week 28 | 6 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Early withdrawal | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 2 | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 4 | 9 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 8 | 19 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 16 | 32 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 20 | 37 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 24 | 38 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 28 | 44 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 32 | 47 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 36 | 48 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 40 | 49 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 44 | 53 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 48 | 56 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 52 | 54 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an ACR70 Response | Week 12 | 30 participants |
Secondary
Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response
A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in TJC (68 joints) and SJC (66 joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0 mm=no disease activity to 100 mm=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0 mm=no pain to 100 mm=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, averaged to 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either C-reactive protein \[CRP\] or ESR).
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 16 | 13 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 32 | 13 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 4 | 6 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 36 | 12 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 20 | 15 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 40 | 13 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 12 | 10 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 44 | 12 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 24 | 15 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 48 | 12 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 8 | 11 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 52 | 12 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 28 | 14 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Early withdrawal | 3 participants |
| Tocilizumab Monotherapy | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 2 | 6 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Early withdrawal | 10 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 2 | 23 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 4 | 68 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 8 | 69 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 12 | 83 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 16 | 83 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 20 | 86 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 24 | 90 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 28 | 87 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 32 | 89 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 36 | 92 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 40 | 91 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 44 | 88 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 48 | 87 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | Week 52 | 88 participants |
Secondary
Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records
A diary card was provided to participants to record home injections. Participants were asked to return all empty drug supply boxes, unused pre-filled syringe, and diary cards to the clinic at each visit as a measure of drug accountability and participant compliance. A participant was considered compliant if the participant correctly administered all scheduled doses of SC tocilizumab during the assessment period.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Baseline | 21 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 28 | 19 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 12 | 18 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 32 | 17 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 4 | 20 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 36 | 17 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 16 | 19 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 40 | 16 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 2 | 20 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 44 | 16 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 20 | 18 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 48 | 13 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 8 | 18 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 52 | 16 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 24 | 16 participants |
| Tocilizumab Monotherapy | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Early withdrawal | 4 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 24 | 107 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Baseline | 137 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 2 | 126 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 4 | 132 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 8 | 124 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 12 | 121 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 16 | 120 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 20 | 114 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Early withdrawal | 27 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 28 | 112 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 32 | 111 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 36 | 105 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 40 | 104 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 44 | 102 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 48 | 107 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | Week 52 | 98 participants |
Secondary
Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Baseline | 0 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 12 | 6 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 32 | 5 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 4 | 9 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 36 | 1 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 16 | 3 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 40 | 3 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 2 | 7 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 44 | 5 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 20 | 3 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 48 | 3 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 8 | 3 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 52 | 0 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 24 | 2 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Early withdrawal | 2 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 28 | 4 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Early withdrawal | 4 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Baseline | 5 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 2 | 18 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 4 | 30 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 8 | 25 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 12 | 23 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 16 | 20 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 20 | 15 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 24 | 15 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 28 | 15 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 32 | 14 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 36 | 14 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 40 | 14 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 44 | 10 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 48 | 12 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2 | Week 52 | 11 participants |
Secondary
Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6
DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR \<2.6 implied clinical remission.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Early withdrawal | 3 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Baseline | 0 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 2 | 1 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 4 | 2 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 8 | 5 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 12 | 6 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 16 | 10 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 20 | 11 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 24 | 14 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 28 | 14 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 32 | 12 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 36 | 14 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 40 | 13 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 44 | 10 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 48 | 11 participants |
| Tocilizumab Monotherapy | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 52 | 12 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 52 | 80 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Early withdrawal | 7 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 24 | 76 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Baseline | 3 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 40 | 81 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 2 | 15 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 28 | 73 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 4 | 34 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 48 | 78 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 8 | 53 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 32 | 80 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 12 | 66 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 44 | 80 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 16 | 72 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 36 | 80 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6 | Week 20 | 75 participants |
Secondary
Number of Participants With Anti-Tocilizumab Antibodies
Time frame: Baseline, Weeks 12 and 24, at early withdrawal (up to Week 52), and follow-up visit (8 weeks after last dose of tocilizumab, up to 60 weeks)
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab Monotherapy | Number of Participants With Anti-Tocilizumab Antibodies | Baseline | 3 participants |
| Tocilizumab Monotherapy | Number of Participants With Anti-Tocilizumab Antibodies | Early withdrawal | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Anti-Tocilizumab Antibodies | Follow-up visit | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Anti-Tocilizumab Antibodies | Week 12 | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Anti-Tocilizumab Antibodies | Week 24 | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Anti-Tocilizumab Antibodies | Follow-up visit | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Anti-Tocilizumab Antibodies | Baseline | 6 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Anti-Tocilizumab Antibodies | Week 24 | 2 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Anti-Tocilizumab Antibodies | Early withdrawal | 0 participants |
Secondary
Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR
DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). DAS28-ESR scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. The DAS28-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline \>1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline \>1.2 with a DAS28 score \>3.2 or a change from baseline \>0.6 to ≤1.2 with a DAS28 score ≤5.1. Participants with change from baseline \>0.6 to ≤1.2 with a DAS28 score \>5.1, or any score with change from baseline ≤0.6, were assessed as non-responders.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 28: No response | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 12: Moderate response | 3 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 28: Moderate response | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 2: No response | 4 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 28: Good response | 18 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 12: Good response | 12 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 32: No response | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 32: Moderate response | 2 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 4: Good response | 11 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 32: Good response | 16 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 16: No response | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 36: No response | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 2: Good response | 7 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 36: Moderate response | 3 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 36: Good response | 15 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 16: Moderate response | 4 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 40: No response | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 8: No response | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 40: Moderate response | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 16: Good response | 13 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 40: Good response | 16 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 44: No response | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 20: No response | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 44: Moderate response | 2 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 8: Moderate response | 9 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 44: Good response | 15 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 20: Moderate response | 5 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 48: No response | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 4: No response | 3 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 48: Moderate response | 2 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 20: Good response | 14 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 48: Good response | 14 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 8: Good response | 8 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 52: No response | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 24: No response | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 52: Moderate response | 3 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 2: Moderate response | 10 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 52: Good response | 12 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 24: Moderate response | 2 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Early Withdrawal: No response | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 12: No response | 4 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Early Withdrawal: Moderate response | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 24: Good response | 16 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Early Withdrawal: Good response | 4 participants |
| Tocilizumab Monotherapy | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 4: Moderate response | 7 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Early Withdrawal: Good response | 9 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 36: Moderate response | 19 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 2: No response | 56 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 2: Moderate response | 56 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 2: Good response | 25 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 4: No response | 22 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 4: Moderate response | 58 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 4: Good response | 57 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 8: No response | 11 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 8: Moderate response | 48 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 8: Good response | 72 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 12: No response | 11 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 12: Moderate response | 34 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 12: Good response | 83 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 16: No response | 9 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 16: Moderate response | 30 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 16: Good response | 86 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 20: No response | 9 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 20: Moderate response | 27 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 20: Good response | 85 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 24: No response | 7 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 24: Moderate response | 21 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 24: Good response | 89 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 28: No response | 5 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 28: Moderate response | 24 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 28: Good response | 86 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 32: Moderate response | 21 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 32: Good response | 91 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 36: No response | 4 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 36: Good response | 91 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 40: No response | 2 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 40: Moderate response | 15 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 40: Good response | 94 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 44: No response | 5 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 44: Moderate response | 15 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 44: Good response | 87 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 48: No response | 4 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 48: Moderate response | 13 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 48: Good response | 90 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 52: No response | 5 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 52: Moderate response | 12 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 52: Good response | 90 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Early Withdrawal: No response | 11 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Early Withdrawal: Moderate response | 8 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | Week 32: No response | 3 participants |
Secondary
Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation
Results are reported for number of participants who had non-biologic DMARD/corticosteroid dose reductions and/or discontinuation by reasons for dose reductions or discontinuation (safety reasons, discomfort, lack of efficacy, other reasons, and unknown reasons). Participants may be included under more than one reason.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, at early withdrawal (up to Week 52), follow-up Week 4 (up to Week 56), and follow-up Week 8 (up to Week 60)
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 8: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Baseline: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Baseline: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Baseline: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Baseline: Other | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 16: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 16: Other | 2 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 28: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Baseline: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 2: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 2: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 2: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 2: Other | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 2: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 4: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 4: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 4: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 4: Other | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 4: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 8: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 8: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 8: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 8: Other | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 12: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 12: Discomfort 8 | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 12: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 12: Other | 2 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 12: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 16: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 16: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 16: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 20: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 20: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 20: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 20: Other | 2 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 20: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 24: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 24:Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 24: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 24: Other | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 24: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 28: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 28: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 28: Other | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 28: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 32: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 32: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 32: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 32: Other | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 32: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 36: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 36: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 36: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 36: Other | 2 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 36: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 40: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 40: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 40: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 40: Other | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 40: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 44: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 44: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 44: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 44: Other | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 44: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 48: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 48: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 48: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 48: Other | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 48: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 52: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 52: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 52: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 52: Other | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 52: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Early withdrawal: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Early withdrawal: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Early withdrawal: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Early withdrawal: Other | 1 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Early withdrawal: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 4: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 4: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 4: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 4: Other | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 4: Unknown | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 8: Safety | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 8: Discomfort | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 8: Lack of efficacy | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 8: Other | 0 participants |
| Tocilizumab Monotherapy | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 8: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 48: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 28: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Baseline: Safety | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Early withdrawal: Other | 8 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Baseline: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 32: Safety | 4 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Baseline: Lack of efficacy | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 48: Lack of efficacy | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Baseline: Other | 2 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 32: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 16: Lack of efficacy | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 52: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 4: Unknown | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 36: Discomfort | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 32: Lack of efficacy | 2 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Baseline: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 48: Other | 3 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 2: Safety | 4 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 32: Other | 11 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 2: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Early withdrawal: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 2: Lack of efficacy | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 32: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 2: Other | 7 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 48: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 2: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 36: Safety | 3 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 4: Safety | 6 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 8: Lack of efficacy | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 4: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 52: Safety | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 4: Lack of efficacy | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 36: Lack of efficacy | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 4: Other | 9 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 4: Safety | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 4: Unknown | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 36: Other | 3 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 8: Safety | 8 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 8: Safety | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 8: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 36: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 8: Lack of efficacy | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 52: Lack of efficacy | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 8: Other | 13 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 40: Lack of efficacy | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 8: Unknown | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 40: Safety | 4 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 12: Safety | 6 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 4: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 12: Discomfort 8 | 2 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 40: Discomfort | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 12: Lack of efficacy | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 52: Other | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 12: Other | 14 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 8: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 12: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 40: Other | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 16: Safety | 7 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 52: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 16: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 16: Other | 13 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 40: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 16: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 4: Lack of efficacy | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 20: Safety | 6 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 44: Safety | 3 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 20: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Early withdrawal: Safety | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 20: Lack of efficacy | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 44: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 20: Other | 9 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 8: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 20: Unknown | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 44: Lack of efficacy | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 24: Safety | 5 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Early withdrawal: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 24:Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 44: Other | 7 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 24: Lack of efficacy | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 4: Other | 2 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 24: Other | 13 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 44: Unknown | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 24: Unknown | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Early withdrawal: Lack of efficacy | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 28: Safety | 3 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 48: Safety | 3 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 28: Discomfort | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 28: Lack of efficacy | 1 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Follow-up Week 8: Other | 0 participants |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation | Week 28: Other | 7 participants |
Secondary
Patient Global Assessment of Disease Activity VAS Score
Patient global assessment of disease activity was measured on a 0 to 100 mm horizontal VAS where 0 mm=no disease activity and 100 mm=maximum disease activity.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 28 | 23.2 mm | Standard Deviation 16.47 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 12 | 41.3 mm | Standard Deviation 27.67 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 32 | 24.0 mm | Standard Deviation 17.81 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 4 | 46.4 mm | Standard Deviation 26.43 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 36 | 24.1 mm | Standard Deviation 19.13 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 16 | 29.6 mm | Standard Deviation 21.59 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 40 | 22.5 mm | Standard Deviation 19.31 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 2 | 50.3 mm | Standard Deviation 24.01 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 44 | 22.7 mm | Standard Deviation 20.62 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 20 | 25.7 mm | Standard Deviation 23.77 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 48 | 22.9 mm | Standard Deviation 23.31 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 8 | 35.8 mm | Standard Deviation 24.73 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 52 | 20.6 mm | Standard Deviation 18.96 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Week 24 | 23.8 mm | Standard Deviation 19.55 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Early withdrawal | 30.8 mm | Standard Deviation 28.78 |
| Tocilizumab Monotherapy | Patient Global Assessment of Disease Activity VAS Score | Baseline | 59.6 mm | Standard Deviation 26.94 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Early withdrawal | 52.4 mm | Standard Deviation 24.88 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 2 | 54.5 mm | Standard Deviation 22.12 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 4 | 42.3 mm | Standard Deviation 23.22 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 8 | 36.2 mm | Standard Deviation 24.43 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 12 | 32.1 mm | Standard Deviation 23.91 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 16 | 29.2 mm | Standard Deviation 22.55 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 20 | 29.9 mm | Standard Deviation 22.99 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 24 | 26.6 mm | Standard Deviation 21.92 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 28 | 26.7 mm | Standard Deviation 23.12 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 32 | 24.3 mm | Standard Deviation 21.66 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 36 | 22.3 mm | Standard Deviation 21.86 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 40 | 21.4 mm | Standard Deviation 20.81 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 44 | 22.0 mm | Standard Deviation 22.83 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 48 | 18.9 mm | Standard Deviation 20.57 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Week 52 | 21.4 mm | Standard Deviation 23.07 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Global Assessment of Disease Activity VAS Score | Baseline | 62.3 mm | Standard Deviation 20.72 |
Secondary
Patient Pain VAS Score
This assessment represents the participant's assessment of his/her current level of pain on a 100 mm horizontal VAS where 0 mm= no pain to 100 mm= unbearable pain.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)
Population: FAS populations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 8 | 37.8 mm | Standard Deviation 25.75 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Early withdrawal | 30.4 mm | Standard Deviation 29.57 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Baseline | 50.5 mm | Standard Deviation 23.78 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 2 | 46.1 mm | Standard Deviation 22.43 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 4 | 47.0 mm | Standard Deviation 26.69 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 12 | 40.9 mm | Standard Deviation 29.56 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 16 | 29.7 mm | Standard Deviation 20.83 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 20 | 27.6 mm | Standard Deviation 25.48 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 24 | 29.9 mm | Standard Deviation 22.76 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 28 | 24.8 mm | Standard Deviation 19.15 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 32 | 25.1 mm | Standard Deviation 17.92 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 36 | 29.6 mm | Standard Deviation 20.03 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 40 | 27.6 mm | Standard Deviation 22.7 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 44 | 26.7 mm | Standard Deviation 24.25 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 48 | 28.6 mm | Standard Deviation 28.98 |
| Tocilizumab Monotherapy | Patient Pain VAS Score | Week 52 | 22.4 mm | Standard Deviation 19.7 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 20 | 28.6 mm | Standard Deviation 23.74 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 36 | 22.1 mm | Standard Deviation 21.68 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 52 | 19.0 mm | Standard Deviation 19.83 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Early withdrawal | 51.6 mm | Standard Deviation 26.03 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 24 | 25.2 mm | Standard Deviation 22.16 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Baseline | 57.5 mm | Standard Deviation 21.06 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 44 | 20.0 mm | Standard Deviation 21.26 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 2 | 51.1 mm | Standard Deviation 22.58 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 28 | 25.6 mm | Standard Deviation 23.18 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 4 | 42.4 mm | Standard Deviation 23.8 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 8 | 35.3 mm | Standard Deviation 24.3 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 40 | 20.9 mm | Standard Deviation 21.24 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 12 | 30.8 mm | Standard Deviation 23.29 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 32 | 22.6 mm | Standard Deviation 21.3 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 16 | 26.8 mm | Standard Deviation 22.61 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Patient Pain VAS Score | Week 48 | 17.6 mm | Standard Deviation 19.66 |
Secondary
Percentage of Methotrexate Adherence as Assessed by Methotrexate Adherence Questionnaire
Methotrexate adherence was determined from responses to the question 'Over the last 3 months you were prescribed 12 doses of methotrexate, how many (approximately) have you taken?' Adherence (%) was calculated as: (Approximate number of doses taken/12)\*100.
Time frame: Baseline, Weeks 12, 24, 36, 52, and at early withdrawal (up to Week 52)
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome. Results are provided for single arm as participants in Tocilizumab Monotherapy arm did not receive methotrexate.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Monotherapy | Percentage of Methotrexate Adherence as Assessed by Methotrexate Adherence Questionnaire | Baseline | 96.82 percentage of methotrexate adherence | Standard Deviation 7.747 |
| Tocilizumab Monotherapy | Percentage of Methotrexate Adherence as Assessed by Methotrexate Adherence Questionnaire | Week 12 | 92.92 percentage of methotrexate adherence | Standard Deviation 14.412 |
| Tocilizumab Monotherapy | Percentage of Methotrexate Adherence as Assessed by Methotrexate Adherence Questionnaire | Week 24 | 91.54 percentage of methotrexate adherence | Standard Deviation 20.915 |
| Tocilizumab Monotherapy | Percentage of Methotrexate Adherence as Assessed by Methotrexate Adherence Questionnaire | Week 36 | 90.14 percentage of methotrexate adherence | Standard Deviation 21.456 |
| Tocilizumab Monotherapy | Percentage of Methotrexate Adherence as Assessed by Methotrexate Adherence Questionnaire | Week 52 | 95.28 percentage of methotrexate adherence | Standard Deviation 11.417 |
| Tocilizumab Monotherapy | Percentage of Methotrexate Adherence as Assessed by Methotrexate Adherence Questionnaire | Early withdrawal | 90.69 percentage of methotrexate adherence | Standard Deviation 18.367 |
Secondary
Percent Change From Baseline in Total SJC on 66 Joints at Week 52
Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 66. A reduction in number of swollen joints compared to baseline indicates improvement. The outcome is reported as the percent change from baseline to end of treatment (52 weeks).
Time frame: Baseline, Week 52
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Percent Change From Baseline in Total SJC on 66 Joints at Week 52 | -89.31 percent change | Standard Deviation 20.059 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Percent Change From Baseline in Total SJC on 66 Joints at Week 52 | -74.77 percent change | Standard Deviation 66.277 |
Secondary
Percent Change From Baseline in Total TJC on 68 Joints at Week 52
Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 68. A reduction in number of tender joints compared to baseline indicates improvement. The outcome is reported as the percent change from baseline to end of treatment (52 weeks).
Time frame: Baseline, Week 52
Population: FAS population. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab Monotherapy | Percent Change From Baseline in Total TJC on 68 Joints at Week 52 | -83.12 percent change | Standard Deviation 26.607 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Percent Change From Baseline in Total TJC on 68 Joints at Week 52 | -80.44 percent change | Standard Deviation 41.226 |
Secondary
Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs)
Time frame: Baseline, Weeks 12 and 24, at early withdrawal (up to Week 52), and follow-up visit (8 weeks after last dose of tocilizumab, up to 60 weeks)
Population: FAS population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Monotherapy | Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) | Early withdrawal | 639.75 nanograms per milliliter (ng/mL) | Standard Deviation 99.644 |
| Tocilizumab Monotherapy | Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) | Baseline | 43.63 nanograms per milliliter (ng/mL) | Standard Deviation 10.947 |
| Tocilizumab Monotherapy | Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) | Week 12 | 577.42 nanograms per milliliter (ng/mL) | Standard Deviation 175.649 |
| Tocilizumab Monotherapy | Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) | Week 24 | 602.25 nanograms per milliliter (ng/mL) | Standard Deviation 158.541 |
| Tocilizumab Monotherapy | Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) | Follow-up visit | 132.23 nanograms per milliliter (ng/mL) | Standard Deviation 93.048 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) | Follow-up visit | 125.07 nanograms per milliliter (ng/mL) | Standard Deviation 211.038 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) | Week 24 | 521.07 nanograms per milliliter (ng/mL) | Standard Deviation 160.464 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) | Baseline | 42.40 nanograms per milliliter (ng/mL) | Standard Deviation 12.087 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) | Early withdrawal | 327.95 nanograms per milliliter (ng/mL) | Standard Deviation 229.481 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) | Week 12 | 548.70 nanograms per milliliter (ng/mL) | Standard Deviation 131.079 |
Secondary
Serum Levels of Tocilizumab
Time frame: Baseline, Weeks 12 and 24, at early withdrawal (up to Week 52), and follow-up visit (8 weeks after last dose of tocilizumab, up to 60 weeks)
Population: FAS population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Monotherapy | Serum Levels of Tocilizumab | Week 12 | 35.3953 micrograms per milliliter (mcg/mL) | Standard Deviation 22.69069 |
| Tocilizumab Monotherapy | Serum Levels of Tocilizumab | Early withdrawal | 44.7160 micrograms per milliliter (mcg/mL) | Standard Deviation 38.81521 |
| Tocilizumab Monotherapy | Serum Levels of Tocilizumab | Week 24 | 53.0416 micrograms per milliliter (mcg/mL) | Standard Deviation 39.06367 |
| Tocilizumab Monotherapy | Serum Levels of Tocilizumab | Follow-up visit | 0.0597 micrograms per milliliter (mcg/mL) | Standard Deviation 0.10335 |
| Tocilizumab Monotherapy | Serum Levels of Tocilizumab | Baseline | 0.0000 micrograms per milliliter (mcg/mL) | Standard Deviation 0 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Serum Levels of Tocilizumab | Follow-up visit | 2.3123 micrograms per milliliter (mcg/mL) | Standard Deviation 7.40931 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Serum Levels of Tocilizumab | Baseline | 0.0082 micrograms per milliliter (mcg/mL) | Standard Deviation 0.09619 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Serum Levels of Tocilizumab | Week 12 | 40.2529 micrograms per milliliter (mcg/mL) | Standard Deviation 21.05801 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Serum Levels of Tocilizumab | Week 24 | 43.9047 micrograms per milliliter (mcg/mL) | Standard Deviation 30.41603 |
| Tocilizumab in Combination With Methotrexate or Other DMARDs | Serum Levels of Tocilizumab | Early withdrawal | 17.6160 micrograms per milliliter (mcg/mL) | Standard Deviation 22.92477 |