Rheumatoid Arthritis
Conditions
Brief summary
This was a multicenter, open-label extension (OLE) Phase II study designed to evaluate the long-term efficacy and safety of ALX-0061 (i.e., vobarilizumab) administered subcutaneously (s.c.) in subjects with active rheumatoid arthritis (RA) who had completed the treatment and assessment period of one of the preceding Phase IIb studies with ALX-0061 (ALX0061-C201 and ALX0061-C202; placebo and ALX-0061 treatment arms only), and who achieved at least 20% improvement in swollen joint count (SJC) and/or tender joint count (TJC) (66/68 counts) compared to Baseline at the final visit of the preceding study (i.e., Week 24 for Study ALX0061-C201 and Week 12 for Study ALX0061-C202).
Detailed description
Eligible subjects received one of the following treatments during the preceding Phase IIb studies ALX0061-C201 and ALX0061-C202: * Study ALX0061-C201: * Placebo (+ methotrexate \[MTX\]), or * ALX-0061 75 mg every 4 weeks (q4w) (+ MTX), or * ALX-0061 150 mg q4w (+ MTX), or * ALX-0061 150 mg every 2 weeks (q2w) (+ MTX), or * ALX-0061 225 mg q2w (+ MTX), for 24 weeks * Study ALX0061-C202: * ALX-0061 150 mg q4w, or * ALX-0061 150 mg q2w, or * ALX-0061 225 mg q2w, for 12 weeks At the Week 24 (ALX0061-C201) or Week 12 (ALX0061-C202) visit of the previous study, informed consent was obtained from all subjects who were deemed potentially eligible for the OLE study, according to the inclusion and exclusion criteria. This was marked as the Week 0 visit of the C203 study. Of note, the Baseline time point in the analyses of this study was defined the Baseline value of the parent study. In this OLE study, eligible subjects received ALX-0061 150 mg s.c. injections, beginning at Week 0 and every 2 weeks thereafter, up to and including Week 102. Eligible subjects from the preceding study ALX0061-C201 also continued their MTX treatment. Maintenance of the response (i.e., at least 20% improvement in both SJC and TJC compared to Baseline of the preceding study) was reassessed at the study visits at Weeks 12, 24, 36, 48, 60, 72, 84, and 96. Subjects who failed to maintain response and met the Efficacy Discontinuation Criteria were discontinued from this study.
Interventions
BIOLOGICALALX-0061
Subjects received ALX-0061 150 mg s.c. injections, beginning at Week 0 and q2w thereafter, up to and including Week 102. Subjects from the preceding study ALX0061-C201 also continued their MTX treatment.
Sponsors
Ablynx, a Sanofi company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Must have been eligible for one of the preceding Phase IIb studies with ALX-0061 (study ALX0061-C201 or ALX0061-C202), have been randomized to placebo or one of the ALX-0061 arms (subjects randomized to tocilizumab \[TCZ\] in study ALX0061-C202 were not eligible), and completed the entire treatment and assessment period of the preceding studies (i.e., 24 weeks for study ALX0061-C201 and 12 weeks for study ALX0061-C202). * Must have reached at least 20% improvement in SJC and/or TJC (66/68 counts) compared to Week 0 at Week 24 for subjects participating in the preceding Phase IIb ALX0061 C201 study, or at Week 12 for subjects participating in the preceding Phase IIb ALX0061-C202 study * Female subjects of childbearing potential (excluding postmenopausal women, sterilized, ovariectomized, and hysterectomized women) must agree to use 2 generally accepted adequate contraceptive methods of which 1 is a barrier method (e.g., hormonal contraception stabilized for at least 1 month \[oral, patch, depot, injectable, vaginal ring\] in combination with condom by partner) or should agree upon continuous abstinence from heterosexual contact from screening/baseline until at least 6 months after last dosing. Male subjects must use condoms for the duration of the study and for at least 6 months after last administration of study drug. * Ability to comprehend and willingness to sign the informed consent form (ICF). * An understanding of and ability and willingness to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
* Received TCZ during the previous Study ALX0061-C202. * Received any prohibited treatment during the previous Phase IIb studies (ALX0061-C201 or ALX0061-C202. * Diagnosis of or suspicion of a serious infection (requiring parental antibiotics and/or hospitalization) or tuberculosis during the preceding study. * Diagnosis of malignancy or demyelinating disease during the preceding study. * Any active or recurrent viral infection that made the subject unsuitable for the study based on the Investigator's clinical assessment, including recurrent/disseminated herpes zoster. * Diagnosis of congestive heart failure class III or IV (as defined by the New York Heart Association), unstable angina pectoris, myocardial infarction, and/or cerebrovascular accident during the preceding study. * Abnormality in laboratory test results observed at the Week 22 visit for subjects participating in the preceding Phase IIb ALX0061-C201 study, or observed at the Week 10 visit for subjects participating in the preceding Phase IIb ALX0061-C202 study: 1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels ≥ 2 times the upper limit of normal (ULN). 2. Hemoglobin levels ≤ 85 g/L (8.5 g/dL). 3. Platelet count ≤ 75 x 109/L (75,000 cells/mm³). 4. Absolute neutrophil count \< 1.5 x 109/L. 5. Serum creatinine levels ≥ 1.5 mg/dL (133 μmol/L). 6. Any other clinically significant abnormal laboratory result as evaluated by the Investigator. 7. If no laboratory test results of the Week 22 Visit (for subjects participating in the preceding ALX0061-C201 study) or the Week 10 Visit (for subjects participating in the preceding ALX0061-C202 study) were available, then laboratory values of tests performed between Week 22 and 24 (for study ALX0061-C201) or Week 10 and 12 (for study ALX0061-C202) were taken into account for the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. | At Weeks 0, 12, 48, and 104 | ACR 20 response is defined as: * 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND * 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND * 20% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - visual analogue scale \[VAS\]) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) * C-reactive protein (CRP) level ACR20 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported. |
| Number and Percentage of Subjects With ACR50 Response. | At Weeks 0, 12, 48, and 104 | ACR50 response is defined as: * 50% improvement in TJC (68 joints) relative to Week 0 AND * 50% improvement in SJC (66 joints) relative to Week 0 AND * 50% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - VAS) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by HAQ-DI * CRP level ACR50 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported. |
| Number and Percentage of Subjects With ACR70 Response. | At Weeks 0, 12, 48, and 104 | ACR70 response is defined as: * 70% improvement in TJC (68 joints) relative to Week 0 AND * 70% improvement in SJC (66 joints) relative to Week 0 AND * 70% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - VAS) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by HAQ-DI * CRP level ACR70 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported. |
| ACR-N Index of Improvement | At Weeks 0, 12, 48, and 104 | The ACR-N Index of Improvement is defined as the minimum of the following 3 criteria: * The percent improvement from Week 0 in TJCs * The percent improvement from Week 0 in SJCs * The median percent improvement from Week 0 for the following 5 assessments: * Subject's assessment of pain (VAS) * Subject's global assessment of disease activity (VASPHA) * Physician's global assessment of disease activity (VASPHA) * Subject's assessment of physical function as measured by the HAQ-DI * CRP level ACR-N Index of Improvement was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported. |
| Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | At Weeks 0, 12, 48, and 104 | DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln\[ESR\]) +(0.014 × VASPA) * Remission = DAS28(ESR) \< 2.6 * Low disease activity = 2.6 ≤ DAS28 ≤ 3.2 * Moderate disease activity = 3.2 \< DAS28 ≤ 5.1 * High disease activity = DAS28 \> 5.1 Disease activity based on DAS28(ESR) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported. |
| Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | At Weeks 0, 12, 48, and 104 | DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln\[CRP+1\]) + (0.014 × VASPA) + 0.96 * DAS28(CRP) \< 2.6 * Low disease activity = 2.6 ≤ DAS28 ≤ 3.2 * Moderate disease activity = 3.2 \< DAS28 ≤ 5.1 * High disease activity = DAS28 \> 5.1 Disease activity based on DAS28(CRP) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported. |
Countries
Belgium, Bulgaria, Georgia, Germany, Hungary, Mexico, Moldova, North Macedonia, Poland, Romania, Serbia, Spain
Participant flow
Recruitment details
A total of 406 subjects was enrolled at 56 sites located in Europe (48 sites, 333 subjects) and Latin America (8 sites, 73 subjects). Consent was obtained from the first subject on 13 July 2015; the last subject completed the final visit on 23 August 2018.
Pre-assignment details
A total of 472 subjects completed the entire treatment and assessment period of the preceding Phase IIb studies (placebo and ALX-0061 treatment arms only). Of these, 406 subjects were enrolled in this study. All screened subjects were included in the Intent-to-observe (ITO) Population. Overall, 405 subjects were included in the Safety Population.
Participants by arm
| Arm | Count |
|---|---|
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) ALX-0061 150 mg s.c. q2w + MTX | 257 |
| ALX-0061 150 mg q2w (C202 All Subjects) ALX-0061 150 mg s.c. q2w | 149 |
| Total | 406 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 23 | 11 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lack of Efficacy | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Non-Compliance with Study Drug | 1 | 0 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Pregnancy Wish | 3 | 0 |
| Overall Study | Relocation | 2 | 1 |
| Overall Study | Sponsor's Decision | 0 | 3 |
| Overall Study | Withdrawal by Subject | 17 | 9 |
Baseline characteristics
| Characteristic | ALX-0061 150 mg q2w (C202 All Subjects) | ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 21 Participants | 44 Participants | 65 Participants |
| Age, Categorical Between 18 and 65 years | 127 Participants | 212 Participants | 339 Participants |
| Age, Continuous | 51.1 years STANDARD_DEVIATION 12.01 | 51.7 years STANDARD_DEVIATION 12.26 | 51.5 years STANDARD_DEVIATION 12.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 53 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 128 Participants | 204 Participants | 332 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 12 Participants | 12 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 149 Participants | 244 Participants | 393 Participants |
| Region of Enrollment Belgium | 7 participants | 9 participants | 16 participants |
| Region of Enrollment Bulgaria | 15 participants | 23 participants | 38 participants |
| Region of Enrollment Georgia | 30 participants | 35 participants | 65 participants |
| Region of Enrollment Germany | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Hungary | 6 participants | 20 participants | 26 participants |
| Region of Enrollment Macedonia | 12 participants | 9 participants | 21 participants |
| Region of Enrollment Mexico | 21 participants | 52 participants | 73 participants |
| Region of Enrollment Moldova | 18 participants | 4 participants | 22 participants |
| Region of Enrollment Poland | 24 participants | 81 participants | 105 participants |
| Region of Enrollment Romania | 1 participants | 2 participants | 3 participants |
| Region of Enrollment Serbia | 12 participants | 20 participants | 32 participants |
| Region of Enrollment Spain | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 124 Participants | 217 Participants | 341 Participants |
| Sex: Female, Male Male | 25 Participants | 40 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 257 | 0 / 148 | 2 / 405 |
| other Total, other adverse events | 122 / 257 | 96 / 148 | 218 / 405 |
| serious Total, serious adverse events | 25 / 257 | 9 / 148 | 34 / 405 |
Outcome results
Primary
ACR-N Index of Improvement
The ACR-N Index of Improvement is defined as the minimum of the following 3 criteria: * The percent improvement from Week 0 in TJCs * The percent improvement from Week 0 in SJCs * The median percent improvement from Week 0 for the following 5 assessments: * Subject's assessment of pain (VAS) * Subject's global assessment of disease activity (VASPHA) * Physician's global assessment of disease activity (VASPHA) * Subject's assessment of physical function as measured by the HAQ-DI * CRP level ACR-N Index of Improvement was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.
Time frame: At Weeks 0, 12, 48, and 104
Population: ITO Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | ACR-N Index of Improvement | Week 12 | 61.51 percent improvement | Standard Error 1.643 |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | ACR-N Index of Improvement | Week 48 | 67.73 percent improvement | Standard Error 1.691 |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | ACR-N Index of Improvement | Week 0 | 55.77 percent improvement | Standard Error 1.703 |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | ACR-N Index of Improvement | Week 104 | 74.83 percent improvement | Standard Error 1.554 |
| ALX-0061 150 mg q2w (C202 All Subjects) | ACR-N Index of Improvement | Week 104 | 73.82 percent improvement | Standard Error 2.171 |
| ALX-0061 150 mg q2w (C202 All Subjects) | ACR-N Index of Improvement | Week 12 | 57.07 percent improvement | Standard Error 2.181 |
| ALX-0061 150 mg q2w (C202 All Subjects) | ACR-N Index of Improvement | Week 0 | 48.18 percent improvement | Standard Error 2.171 |
| ALX-0061 150 mg q2w (C202 All Subjects) | ACR-N Index of Improvement | Week 48 | 66.49 percent improvement | Standard Error 2.048 |
| Total (C203 All Subjects) | ACR-N Index of Improvement | Week 0 | 52.98 percent improvement | Standard Error 1.351 |
| Total (C203 All Subjects) | ACR-N Index of Improvement | Week 104 | 74.45 percent improvement | Standard Error 1.265 |
| Total (C203 All Subjects) | ACR-N Index of Improvement | Week 48 | 67.27 percent improvement | Standard Error 1.306 |
| Total (C203 All Subjects) | ACR-N Index of Improvement | Week 12 | 59.91 percent improvement | Standard Error 1.315 |
Primary
Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)
DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln\[ESR\]) +(0.014 × VASPA) * Remission = DAS28(ESR) \< 2.6 * Low disease activity = 2.6 ≤ DAS28 ≤ 3.2 * Moderate disease activity = 3.2 \< DAS28 ≤ 5.1 * High disease activity = DAS28 \> 5.1 Disease activity based on DAS28(ESR) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.
Time frame: At Weeks 0, 12, 48, and 104
Population: ITO Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 48 | Moderate or High Disease Activity | 51 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 104 | Remission | 146 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 0 | Moderate or High Disease Activity | 113 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 104 | Low Disease Activity | 28 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 0 | Remission | 101 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 12 | Low Disease Activity | 38 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 0 | Low Disease Activity | 39 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 104 | Moderate or High Disease Activity | 24 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 48 | Remission | 139 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 48 | Low Disease Activity | 30 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 12 | Remission | 142 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 12 | Moderate or High Disease Activity | 68 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 104 | Remission | 84 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 0 | Moderate or High Disease Activity | 71 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 12 | Low Disease Activity | 20 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 12 | Moderate or High Disease Activity | 51 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 48 | Low Disease Activity | 27 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 104 | Low Disease Activity | 12 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 0 | Remission | 51 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 0 | Low Disease Activity | 26 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 12 | Remission | 67 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 48 | Remission | 70 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 48 | Moderate or High Disease Activity | 35 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 104 | Moderate or High Disease Activity | 25 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 12 | Moderate or High Disease Activity | 119 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 12 | Remission | 209 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 48 | Low Disease Activity | 57 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 48 | Remission | 209 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 12 | Low Disease Activity | 58 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 104 | Moderate or High Disease Activity | 49 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 48 | Moderate or High Disease Activity | 86 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 0 | Remission | 152 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 104 | Low Disease Activity | 40 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 0 | Low Disease Activity | 65 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 104 | Remission | 230 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) | Week 0 | Moderate or High Disease Activity | 184 Participants |
Primary
Number and Percentage of Subjects With ACR50 Response.
ACR50 response is defined as: * 50% improvement in TJC (68 joints) relative to Week 0 AND * 50% improvement in SJC (66 joints) relative to Week 0 AND * 50% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - VAS) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by HAQ-DI * CRP level ACR50 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.
Time frame: At Weeks 0, 12, 48, and 104
Population: ITO Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With ACR50 Response. | Week 0 | 152 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With ACR50 Response. | Week 104 | 167 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With ACR50 Response. | Week 48 | 170 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With ACR50 Response. | Week 12 | 174 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With ACR50 Response. | Week 104 | 104 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With ACR50 Response. | Week 0 | 70 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With ACR50 Response. | Week 12 | 88 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With ACR50 Response. | Week 48 | 108 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With ACR50 Response. | Week 0 | 222 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With ACR50 Response. | Week 48 | 278 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With ACR50 Response. | Week 104 | 271 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With ACR50 Response. | Week 12 | 262 Participants |
Primary
Number and Percentage of Subjects With ACR70 Response.
ACR70 response is defined as: * 70% improvement in TJC (68 joints) relative to Week 0 AND * 70% improvement in SJC (66 joints) relative to Week 0 AND * 70% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - VAS) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by HAQ-DI * CRP level ACR70 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.
Time frame: At Weeks 0, 12, 48, and 104
Population: ITO Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With ACR70 Response. | Week 104 | 136 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With ACR70 Response. | Week 48 | 135 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With ACR70 Response. | Week 12 | 107 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With ACR70 Response. | Week 0 | 85 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With ACR70 Response. | Week 0 | 33 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With ACR70 Response. | Week 12 | 51 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With ACR70 Response. | Week 48 | 66 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With ACR70 Response. | Week 104 | 89 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With ACR70 Response. | Week 12 | 158 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With ACR70 Response. | Week 0 | 118 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With ACR70 Response. | Week 104 | 225 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With ACR70 Response. | Week 48 | 201 Participants |
Primary
Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response.
ACR 20 response is defined as: * 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND * 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND * 20% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - visual analogue scale \[VAS\]) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) * C-reactive protein (CRP) level ACR20 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.
Time frame: At Weeks 0, 12, 48, and 104
Population: ITO Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. | Week 104 | 193 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. | Week 48 | 209 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. | Week 12 | 221 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. | Week 0 | 224 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. | Week 0 | 126 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. | Week 12 | 130 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. | Week 48 | 126 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. | Week 104 | 117 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. | Week 48 | 335 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. | Week 104 | 310 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. | Week 0 | 350 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. | Week 12 | 351 Participants |
Primary
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln\[CRP+1\]) + (0.014 × VASPA) + 0.96 * DAS28(CRP) \< 2.6 * Low disease activity = 2.6 ≤ DAS28 ≤ 3.2 * Moderate disease activity = 3.2 \< DAS28 ≤ 5.1 * High disease activity = DAS28 \> 5.1 Disease activity based on DAS28(CRP) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.
Time frame: At Weeks 0, 12, 48, and 104
Population: ITO Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 48 | DAS(CRP) < 2.6 | 153 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 12 | DAS(CRP) < 2.6 | 150 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 0 | Moderate or High Disease Activity | 103 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 12 | Low Disease Activity | 41 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 0 | Low Disease Activity | 53 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 12 | Moderate or High Disease Activity | 58 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 104 | Low Disease Activity | 28 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 104 | DAS(CRP) < 2.6 | 160 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 48 | Moderate or High Disease Activity | 35 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 0 | DAS(CRP) < 2.6 | 100 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 104 | Moderate or High Disease Activity | 16 Participants |
| ALX-0061 150 mg q2w + MTX (C201 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 48 | Low Disease Activity | 40 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 48 | DAS(CRP) < 2.6 | 78 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 0 | Low Disease Activity | 34 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 0 | Moderate or High Disease Activity | 66 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 0 | DAS(CRP) < 2.6 | 49 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 12 | DAS(CRP) < 2.6 | 73 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 12 | Low Disease Activity | 23 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 12 | Moderate or High Disease Activity | 46 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 48 | Low Disease Activity | 26 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 48 | Moderate or High Disease Activity | 30 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 104 | DAS(CRP) < 2.6 | 92 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 104 | Low Disease Activity | 20 Participants |
| ALX-0061 150 mg q2w (C202 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 104 | Moderate or High Disease Activity | 11 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 104 | Low Disease Activity | 48 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 0 | Low Disease Activity | 87 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 48 | Moderate or High Disease Activity | 65 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 48 | DAS(CRP) < 2.6 | 231 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 0 | DAS(CRP) < 2.6 | 149 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 104 | DAS(CRP) < 2.6 | 252 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 12 | DAS(CRP) < 2.6 | 223 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 12 | Moderate or High Disease Activity | 104 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 0 | Moderate or High Disease Activity | 169 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 12 | Low Disease Activity | 64 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 104 | Moderate or High Disease Activity | 27 Participants |
| Total (C203 All Subjects) | Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) | Week 48 | Low Disease Activity | 66 Participants |