Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, ACR, Methotrexate, Interleukin-22
Brief summary
The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.
Interventions
OTHERPlacebo
Part 1: Placebo SC administration every 2 weeks X 10 weeks.
DRUGILV-094
Part 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening * Active RA at the time of screening and baseline consisting of \>= 5 swollen and \>= 5 tender joints (28-joint count) and at least 1 of the following at screening: C-reactive protein \>= 10 mg/L or Erythrocyte Sedimentation Rate \>= 28 mm/h * Must be receiving methotrexate for at least 12 weeks, with a stable route and dose (up to 25 mg weekly) for at least 8 weeks prior to the baseline visit.
Exclusion criteria
* Subjects with other rheumatic diseases * Cancer or history of cancer (other than cutaneous basal cell carcinoma and squamous cell carcinoma or in situ cervical cancer) * Any prior use of B cell-depleting therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12 | Week 12 | ACR20 response: greater than or equal to (\>=) 20 percent improvement in tender joint count; \>=20 percent improvement in swollen joint count; and \>=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 2, 4, 6, 8, 10, 12 | ACR50 response: \>=50 percent improvement in tender joint count; \>=50 percent improvement in swollen joint count; and 50 improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP). |
| Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 2, 4, 6, 8, 10, 12 | ACR70 response:\>=70 percent improvement in tender joint count; \>=70 percent improvement in swollen joint count; and 70 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP). |
| Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Baseline, Week 2, 4, 6, 8, 10, 12 | DAS28 (CRP) was calculated from number of swollen joints and tender joints using the 28 joints count; CRP (milligram/Liter \[mg/L\]); and general health visual analog scale (VAS) score (participant rated scale with scores ranging from 0mm \[very well\] to 100mm \[extremely bad\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 (CRP) less than or equal to (\<=) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and less than (\<) 2.6 implied remission. |
| Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Baseline, Week 2, 4, 6, 8, 10, 12 | DAS28 (ESR) was calculated from the number of swollen joints and tender joints using the 28 joints count; ESR (millimeters per hour \[mm/hour\]); and general health VAS score (participant rated scale with scores ranging from 0 \[very well\] to 100 \[extremely bad\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 (ESR) \<=3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity, and \<2.6 implied remission. |
| Tender Joints Counts (TJC) | Baseline, Week 2, 4, 6, 8, 10, 12 | Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. |
| Swollen Joints Count (SJC) | Baseline, Week 2, 4, 6, 8, 10, 12 | Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. |
| Physician Global Assessment of Disease Activity | Baseline, Week 2, 4, 6, 8, 10, 12 | Physician global assessment of disease activity was measured on an 11-point scale, ranging from 0 to 10, where 0 = no disease activity and 10 = extreme disease activity. |
| Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 2, 4, 6, 8, 10 | ACR20 response: \>=20 percent improvement in tender joint count; \>=20 percent improvement in swollen joint count; and \>=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP). |
| Pain Visual Analog Scale (VAS) | Baseline, Week 2, 4, 6, 8, 10, 12 | Participants assessed the amount of pain currently experienced by them on a 100 millimeter (mm) VAS ranging from 0= no pain to 100= severe pain. |
| General Health Visual Analog Scale (VAS) | Baseline, Week 2, 4, 6, 8, 10, 12 | General health VAS is a 100 mm line marked by the participant. Participants were asked, In general how would you rate your health currently concerning the arthritis? Scores ranged from 0 mm = very well to 100 mm = extremely bad. |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline, Week 4, 2, 6, 8, 10, 12 | Health assessment questionnaire-disability index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to perform activity. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
| 36-Item Short-Form Health Survey (SF-36) | Baseline, Week 4, 8, 12 | SF-36 is a standardized survey consisting of 36 items summarized into 8 multi-item scales evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality and mental health. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) derived are derived by aggregating the 8 aspects. The score for each aspect and physical and mental component summary are scaled 0-100 where, higher score indicating highest level of functioning. |
| Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Baseline, Week 4, 8, 12 | FACIT-fatigue is a 13-item questionnaire. Participants score each item on a 5-point scale ranging from 0 (not at all) to 4 (very much). The scoring algorithm is such that the item responses are reversed in score (except for 2 items, I have energy and I am able to do my usual activities), in order to reflect higher scores as less fatigue. The sum of all responses resulted in the FACIT-fatigue total score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. |
| Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 2, 4, 6, 8, 10, 12 | DAS28-based EULAR response criteria was 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: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. |
| Participant Global Assessment of Disease Activity | Baseline, Week 2, 4, 6, 8, 10, 12 | Participants answered: considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a scale ranging from 0 to 10, where 0 = no disease activity and 10 = extreme disease activity. |
Countries
Belgium, Colombia, Croatia, Germany, Hungary, Japan, Mexico, Netherlands, Romania, Russia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to ILV-094 subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration. | 66 |
| ILV-094 100 mg Every 4 Weeks Participants received ILV-094 100 milligram (mg) subcutaneous injection at Day 1 and then every 4 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration. | 39 |
| ILV-094 100 mg Every 2 Weeks Participants received ILV-094 100 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration. | 42 |
| ILV-094 200 mg Every 2 Weeks Participants received ILV-094 200 mg subcutaneous injection at Day 1 and then every 2 weeks up to Week 10. Participants were followed up to 12 weeks after last study drug administration. | 48 |
| Total | 195 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 2 |
| Overall Study | Other | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 0 | 1 | 3 |
Baseline characteristics
| Characteristic | Placebo | ILV-094 100 mg Every 4 Weeks | ILV-094 100 mg Every 2 Weeks | ILV-094 200 mg Every 2 Weeks | Total |
|---|---|---|---|---|---|
| Age, Continuous | 56.91 years STANDARD_DEVIATION 11.01 | 59.95 years STANDARD_DEVIATION 10.3 | 55.14 years STANDARD_DEVIATION 10.8 | 54.90 years STANDARD_DEVIATION 11.11 | 56.64 years STANDARD_DEVIATION 10.93 |
| Sex: Female, Male Female | 53 Participants | 34 Participants | 31 Participants | 38 Participants | 156 Participants |
| Sex: Female, Male Male | 13 Participants | 5 Participants | 11 Participants | 10 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 35 / 66 | 29 / 39 | 26 / 42 | 28 / 48 |
| serious Total, serious adverse events | 7 / 66 | 2 / 39 | 0 / 42 | 0 / 48 |
Outcome results
Primary
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12
ACR20 response: greater than or equal to (\>=) 20 percent improvement in tender joint count; \>=20 percent improvement in swollen joint count; and \>=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).
Time frame: Week 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. Last observation carried forward (LOCF) method was used to impute missing values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12 | 50.0 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12 | 43.6 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12 | 38.1 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12 | 50.0 Percentage of participants |
Comparison: P-value was assessed from 2-sided Cochran-Mantel-Haenszel (CMH) test stratified by anti-tumor necrosis factor (anti-TNF) prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.55895% CI: [-25, 13.3]Cochran-Mantel-Haenszel
Comparison: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.25195% CI: [-30.1, 7.3]Cochran-Mantel-Haenszel
Comparison: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.70795% CI: [-21.7, 14.4]Cochran-Mantel-Haenszel
Secondary
36-Item Short-Form Health Survey (SF-36)
SF-36 is a standardized survey consisting of 36 items summarized into 8 multi-item scales evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality and mental health. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) derived are derived by aggregating the 8 aspects. The score for each aspect and physical and mental component summary are scaled 0-100 where, higher score indicating highest level of functioning.
Time frame: Baseline, Week 4, 8, 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values. Here 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 36-Item Short-Form Health Survey (SF-36) | Baseline: PCS | 33.8 Units on a scale | Standard Deviation 7.8 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) | Baseline: MCS | 40.5 Units on a scale | Standard Deviation 12.3 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) | Week 4: PCS | 36.0 Units on a scale | Standard Deviation 8.2 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) | Week 4: MCS | 42.7 Units on a scale | Standard Deviation 12.4 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) | Week 8: PCS | 35.8 Units on a scale | Standard Deviation 7.5 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) | Week 8: MCS | 44.5 Units on a scale | Standard Deviation 11.3 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) | Week 12: PCS | 36.7 Units on a scale | Standard Deviation 7.7 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) | Week 12: MCS | 43.2 Units on a scale | Standard Deviation 11.8 |
| ILV-094 100 mg Every 4 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 8: MCS | 44.8 Units on a scale | Standard Deviation 12 |
| ILV-094 100 mg Every 4 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 8: PCS | 37.3 Units on a scale | Standard Deviation 8.5 |
| ILV-094 100 mg Every 4 Weeks | 36-Item Short-Form Health Survey (SF-36) | Baseline: MCS | 42.0 Units on a scale | Standard Deviation 12 |
| ILV-094 100 mg Every 4 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 12: MCS | 44.2 Units on a scale | Standard Deviation 11.7 |
| ILV-094 100 mg Every 4 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 12: PCS | 37.6 Units on a scale | Standard Deviation 8.6 |
| ILV-094 100 mg Every 4 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 4: MCS | 43.0 Units on a scale | Standard Deviation 13 |
| ILV-094 100 mg Every 4 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 4: PCS | 36.9 Units on a scale | Standard Deviation 8.5 |
| ILV-094 100 mg Every 4 Weeks | 36-Item Short-Form Health Survey (SF-36) | Baseline: PCS | 34.9 Units on a scale | Standard Deviation 5.8 |
| ILV-094 100 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 12: PCS | 36.3 Units on a scale | Standard Deviation 8.7 |
| ILV-094 100 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 4: PCS | 36.0 Units on a scale | Standard Deviation 8.6 |
| ILV-094 100 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 4: MCS | 41.0 Units on a scale | Standard Deviation 12.2 |
| ILV-094 100 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 8: PCS | 36.6 Units on a scale | Standard Deviation 7.1 |
| ILV-094 100 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 8: MCS | 43.1 Units on a scale | Standard Deviation 11.9 |
| ILV-094 100 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 12: MCS | 44.2 Units on a scale | Standard Deviation 12.6 |
| ILV-094 100 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Baseline: PCS | 34.8 Units on a scale | Standard Deviation 6.6 |
| ILV-094 100 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Baseline: MCS | 41.2 Units on a scale | Standard Deviation 11 |
| ILV-094 200 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 4: PCS | 36.5 Units on a scale | Standard Deviation 7.7 |
| ILV-094 200 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 4: MCS | 40.3 Units on a scale | Standard Deviation 12.4 |
| ILV-094 200 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Baseline: MCS | 41.1 Units on a scale | Standard Deviation 13 |
| ILV-094 200 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Baseline: PCS | 34.4 Units on a scale | Standard Deviation 8.3 |
| ILV-094 200 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 8: PCS | 36.9 Units on a scale | Standard Deviation 8.1 |
| ILV-094 200 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 12: MCS | 44.5 Units on a scale | Standard Deviation 9.8 |
| ILV-094 200 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 12: PCS | 37.1 Units on a scale | Standard Deviation 9.4 |
| ILV-094 200 mg Every 2 Weeks | 36-Item Short-Form Health Survey (SF-36) | Week 8: MCS | 42.9 Units on a scale | Standard Deviation 11.3 |
Secondary
Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP)
DAS28 (CRP) was calculated from number of swollen joints and tender joints using the 28 joints count; CRP (milligram/Liter \[mg/L\]); and general health visual analog scale (VAS) score (participant rated scale with scores ranging from 0mm \[very well\] to 100mm \[extremely bad\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 (CRP) less than or equal to (\<=) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and less than (\<) 2.6 implied remission.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Baseline | 5.6 Units on a scale | Standard Deviation 0.8 |
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 10 | 4.5 Units on a scale | Standard Deviation 1.3 |
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 8 | 4.6 Units on a scale | Standard Deviation 1.3 |
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 2 | 5.1 Units on a scale | Standard Deviation 1 |
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 12 | 4.4 Units on a scale | Standard Deviation 1.3 |
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 4 | 4.9 Units on a scale | Standard Deviation 1.1 |
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 6 | 4.7 Units on a scale | Standard Deviation 1.2 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 10 | 4.2 Units on a scale | Standard Deviation 1.2 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 6 | 4.4 Units on a scale | Standard Deviation 1.2 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 4 | 4.8 Units on a scale | Standard Deviation 0.9 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 8 | 4.4 Units on a scale | Standard Deviation 1.1 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 12 | 4.2 Units on a scale | Standard Deviation 1.4 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 2 | 5.1 Units on a scale | Standard Deviation 1.1 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Baseline | 5.5 Units on a scale | Standard Deviation 0.9 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 6 | 4.6 Units on a scale | Standard Deviation 1.2 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Baseline | 5.3 Units on a scale | Standard Deviation 0.8 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 2 | 4.9 Units on a scale | Standard Deviation 1.4 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 4 | 4.6 Units on a scale | Standard Deviation 1.4 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 8 | 4.4 Units on a scale | Standard Deviation 1.2 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 10 | 4.4 Units on a scale | Standard Deviation 1.2 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 12 | 4.3 Units on a scale | Standard Deviation 1.3 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 4 | 5.0 Units on a scale | Standard Deviation 1.1 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 12 | 4.4 Units on a scale | Standard Deviation 1.3 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 10 | 4.5 Units on a scale | Standard Deviation 1.3 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 2 | 5.2 Units on a scale | Standard Deviation 1 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Baseline | 5.5 Units on a scale | Standard Deviation 0.8 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 8 | 4.4 Units on a scale | Standard Deviation 1.3 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) | Week 6 | 4.6 Units on a scale | Standard Deviation 1.2 |
Secondary
Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR)
DAS28 (ESR) was calculated from the number of swollen joints and tender joints using the 28 joints count; ESR (millimeters per hour \[mm/hour\]); and general health VAS score (participant rated scale with scores ranging from 0 \[very well\] to 100 \[extremely bad\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 (ESR) \<=3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity, and \<2.6 implied remission.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12
Population: mITT population included all randomized participants who received at least 1 or even partial dose of study drug. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Baseline | 6.4 Units on a scale | Standard Deviation 0.7 |
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 10 | 5.2 Units on a scale | Standard Deviation 1.4 |
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 8 | 5.3 Units on a scale | Standard Deviation 1.3 |
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 2 | 5.8 Units on a scale | Standard Deviation 1.1 |
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 12 | 5.1 Units on a scale | Standard Deviation 1.3 |
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 4 | 5.5 Units on a scale | Standard Deviation 1.3 |
| Placebo | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 6 | 5.4 Units on a scale | Standard Deviation 1.3 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 10 | 5.0 Units on a scale | Standard Deviation 1.2 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 6 | 5.2 Units on a scale | Standard Deviation 1.1 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 4 | 5.6 Units on a scale | Standard Deviation 0.9 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 8 | 5.2 Units on a scale | Standard Deviation 1.1 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 12 | 5.0 Units on a scale | Standard Deviation 1.4 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 2 | 5.9 Units on a scale | Standard Deviation 1.1 |
| ILV-094 100 mg Every 4 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Baseline | 6.4 Units on a scale | Standard Deviation 0.8 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 6 | 5.3 Units on a scale | Standard Deviation 1.2 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Baseline | 6.2 Units on a scale | Standard Deviation 0.7 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 2 | 5.6 Units on a scale | Standard Deviation 1.4 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 4 | 5.3 Units on a scale | Standard Deviation 1.3 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 8 | 5.0 Units on a scale | Standard Deviation 1.3 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 10 | 5.0 Units on a scale | Standard Deviation 1.3 |
| ILV-094 100 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 12 | 5.0 Units on a scale | Standard Deviation 1.3 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 4 | 5.7 Units on a scale | Standard Deviation 0.9 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 12 | 5.1 Units on a scale | Standard Deviation 1.3 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 10 | 5.1 Units on a scale | Standard Deviation 1.3 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 2 | 5.9 Units on a scale | Standard Deviation 0.8 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Baseline | 6.3 Units on a scale | Standard Deviation 0.8 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 8 | 5.1 Units on a scale | Standard Deviation 1.2 |
| ILV-094 200 mg Every 2 Weeks | Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) | Week 6 | 5.2 Units on a scale | Standard Deviation 1.2 |
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
FACIT-fatigue is a 13-item questionnaire. Participants score each item on a 5-point scale ranging from 0 (not at all) to 4 (very much). The scoring algorithm is such that the item responses are reversed in score (except for 2 items, I have energy and I am able to do my usual activities), in order to reflect higher scores as less fatigue. The sum of all responses resulted in the FACIT-fatigue total score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time frame: Baseline, Week 4, 8, 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Baseline | 29.1 Units on a scale | Standard Deviation 10.9 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Week 4 | 31.7 Units on a scale | Standard Deviation 10.7 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Week 8 | 32.7 Units on a scale | Standard Deviation 10.8 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Week 12 | 33.3 Units on a scale | Standard Deviation 9.4 |
| ILV-094 100 mg Every 4 Weeks | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Week 4 | 33.6 Units on a scale | Standard Deviation 11.3 |
| ILV-094 100 mg Every 4 Weeks | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Week 8 | 33.7 Units on a scale | Standard Deviation 10.4 |
| ILV-094 100 mg Every 4 Weeks | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Week 12 | 34.3 Units on a scale | Standard Deviation 9.5 |
| ILV-094 100 mg Every 4 Weeks | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Baseline | 30.9 Units on a scale | Standard Deviation 10.9 |
| ILV-094 100 mg Every 2 Weeks | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Week 8 | 32.1 Units on a scale | Standard Deviation 9.9 |
| ILV-094 100 mg Every 2 Weeks | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Week 4 | 32.6 Units on a scale | Standard Deviation 9.8 |
| ILV-094 100 mg Every 2 Weeks | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Week 12 | 32.4 Units on a scale | Standard Deviation 9.5 |
| ILV-094 100 mg Every 2 Weeks | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Baseline | 30.6 Units on a scale | Standard Deviation 9.4 |
| ILV-094 200 mg Every 2 Weeks | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Week 12 | 33.2 Units on a scale | Standard Deviation 10.9 |
| ILV-094 200 mg Every 2 Weeks | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Week 4 | 30.7 Units on a scale | Standard Deviation 10.6 |
| ILV-094 200 mg Every 2 Weeks | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Baseline | 29.2 Units on a scale | Standard Deviation 11.7 |
| ILV-094 200 mg Every 2 Weeks | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Week 8 | 32.3 Units on a scale | Standard Deviation 10.7 |
Secondary
General Health Visual Analog Scale (VAS)
General health VAS is a 100 mm line marked by the participant. Participants were asked, In general how would you rate your health currently concerning the arthritis? Scores ranged from 0 mm = very well to 100 mm = extremely bad.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values. Here 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | General Health Visual Analog Scale (VAS) | Baseline | 60.8 Millimeter | Standard Deviation 18.4 |
| Placebo | General Health Visual Analog Scale (VAS) | Week 10 | 48.4 Millimeter | Standard Deviation 25.7 |
| Placebo | General Health Visual Analog Scale (VAS) | Week 8 | 47.5 Millimeter | Standard Deviation 24.1 |
| Placebo | General Health Visual Analog Scale (VAS) | Week 2 | 54.1 Millimeter | Standard Deviation 22.4 |
| Placebo | General Health Visual Analog Scale (VAS) | Week 12 | 47.6 Millimeter | Standard Deviation 25.4 |
| Placebo | General Health Visual Analog Scale (VAS) | Week 4 | 48.8 Millimeter | Standard Deviation 23 |
| Placebo | General Health Visual Analog Scale (VAS) | Week 6 | 50.7 Millimeter | Standard Deviation 22 |
| ILV-094 100 mg Every 4 Weeks | General Health Visual Analog Scale (VAS) | Week 10 | 38.9 Millimeter | Standard Deviation 22.2 |
| ILV-094 100 mg Every 4 Weeks | General Health Visual Analog Scale (VAS) | Week 6 | 42.4 Millimeter | Standard Deviation 21.9 |
| ILV-094 100 mg Every 4 Weeks | General Health Visual Analog Scale (VAS) | Week 4 | 48.2 Millimeter | Standard Deviation 22.9 |
| ILV-094 100 mg Every 4 Weeks | General Health Visual Analog Scale (VAS) | Week 8 | 40.4 Millimeter | Standard Deviation 23.8 |
| ILV-094 100 mg Every 4 Weeks | General Health Visual Analog Scale (VAS) | Week 12 | 40.6 Millimeter | Standard Deviation 23 |
| ILV-094 100 mg Every 4 Weeks | General Health Visual Analog Scale (VAS) | Week 2 | 52.5 Millimeter | Standard Deviation 23 |
| ILV-094 100 mg Every 4 Weeks | General Health Visual Analog Scale (VAS) | Baseline | 59.2 Millimeter | Standard Deviation 21.2 |
| ILV-094 100 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Week 6 | 52.5 Millimeter | Standard Deviation 19.4 |
| ILV-094 100 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Baseline | 61.0 Millimeter | Standard Deviation 16.4 |
| ILV-094 100 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Week 2 | 53.0 Millimeter | Standard Deviation 23.7 |
| ILV-094 100 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Week 4 | 54.3 Millimeter | Standard Deviation 23.1 |
| ILV-094 100 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Week 8 | 50.3 Millimeter | Standard Deviation 22.2 |
| ILV-094 100 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Week 10 | 46.9 Millimeter | Standard Deviation 24 |
| ILV-094 100 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Week 12 | 47.4 Millimeter | Standard Deviation 22 |
| ILV-094 200 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Week 4 | 52.9 Millimeter | Standard Deviation 20.2 |
| ILV-094 200 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Week 12 | 43.2 Millimeter | Standard Deviation 21.4 |
| ILV-094 200 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Week 10 | 45.7 Millimeter | Standard Deviation 23.3 |
| ILV-094 200 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Week 2 | 54.8 Millimeter | Standard Deviation 19.8 |
| ILV-094 200 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Baseline | 57.7 Millimeter | Standard Deviation 20.7 |
| ILV-094 200 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Week 8 | 45.4 Millimeter | Standard Deviation 21.5 |
| ILV-094 200 mg Every 2 Weeks | General Health Visual Analog Scale (VAS) | Week 6 | 48.8 Millimeter | Standard Deviation 21.9 |
Secondary
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Health assessment questionnaire-disability index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to perform activity. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Baseline, Week 4, 2, 6, 8, 10, 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline | 1.4 Units on a scale | Standard Deviation 0.7 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 10 | 1.2 Units on a scale | Standard Deviation 0.7 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 | 1.2 Units on a scale | Standard Deviation 0.6 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 | 1.3 Units on a scale | Standard Deviation 0.7 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 | 1.2 Units on a scale | Standard Deviation 0.7 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 | 1.3 Units on a scale | Standard Deviation 0.7 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 6 | 1.2 Units on a scale | Standard Deviation 0.7 |
| ILV-094 100 mg Every 4 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 10 | 1.1 Units on a scale | Standard Deviation 0.7 |
| ILV-094 100 mg Every 4 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 6 | 1.1 Units on a scale | Standard Deviation 0.7 |
| ILV-094 100 mg Every 4 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 | 1.1 Units on a scale | Standard Deviation 0.6 |
| ILV-094 100 mg Every 4 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 | 1.1 Units on a scale | Standard Deviation 0.7 |
| ILV-094 100 mg Every 4 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 | 1.1 Units on a scale | Standard Deviation 0.7 |
| ILV-094 100 mg Every 4 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 | 1.3 Units on a scale | Standard Deviation 0.7 |
| ILV-094 100 mg Every 4 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline | 1.3 Units on a scale | Standard Deviation 0.7 |
| ILV-094 100 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 6 | 1.2 Units on a scale | Standard Deviation 0.6 |
| ILV-094 100 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline | 1.3 Units on a scale | Standard Deviation 0.6 |
| ILV-094 100 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 | 1.2 Units on a scale | Standard Deviation 0.7 |
| ILV-094 100 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 | 1.3 Units on a scale | Standard Deviation 0.7 |
| ILV-094 100 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 | 1.2 Units on a scale | Standard Deviation 0.7 |
| ILV-094 100 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 10 | 1.2 Units on a scale | Standard Deviation 0.7 |
| ILV-094 100 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 | 1.1 Units on a scale | Standard Deviation 0.7 |
| ILV-094 200 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 4 | 1.2 Units on a scale | Standard Deviation 0.7 |
| ILV-094 200 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 12 | 1.1 Units on a scale | Standard Deviation 0.7 |
| ILV-094 200 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 10 | 1.1 Units on a scale | Standard Deviation 0.7 |
| ILV-094 200 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 2 | 1.3 Units on a scale | Standard Deviation 0.6 |
| ILV-094 200 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline | 1.3 Units on a scale | Standard Deviation 0.7 |
| ILV-094 200 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 8 | 1.1 Units on a scale | Standard Deviation 0.7 |
| ILV-094 200 mg Every 2 Weeks | Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Week 6 | 1.2 Units on a scale | Standard Deviation 0.7 |
Secondary
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
DAS28-based EULAR response criteria was 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: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1.
Time frame: Week 2, 4, 6, 8, 10, 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 2: None | 47 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 12: Moderate | 33 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 10: Good | 13 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 2: Moderate | 15 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 2: Good | 3 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 12: None | 20 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 8: None | 28 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 6: None | 31 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 10: Moderate | 28 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 8: Moderate | 29 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 6: Moderate | 27 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 6: Good | 7 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 10: None | 24 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 4: None | 41 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 4: Moderate | 20 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 12: Good | 12 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 8: Good | 8 Participants |
| Placebo | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 4: Good | 4 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 10: None | 11 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 8: None | 16 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 10: Good | 6 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 10: Moderate | 22 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 12: Good | 11 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 12: Moderate | 16 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 12: None | 12 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 2: Good | 1 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 2: Moderate | 10 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 2: None | 28 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 4: Good | 2 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 4: Moderate | 13 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 4: None | 24 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 6: Good | 4 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 6: Moderate | 20 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 6: None | 15 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 8: Good | 5 Participants |
| ILV-094 100 mg Every 4 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 8: Moderate | 18 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 4: Moderate | 9 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 10: Moderate | 15 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 4: Good | 6 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 6: Moderate | 11 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 10: None | 21 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 10: Good | 6 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 8: Moderate | 16 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 12: None | 17 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 12: Good | 7 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 4: None | 27 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 6: None | 27 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 2: Good | 5 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 2: None | 30 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 12: Moderate | 18 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 8: Good | 4 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 2: Moderate | 7 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 8: None | 22 Participants |
| ILV-094 100 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 6: Good | 4 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 12: Good | 9 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 2: None | 39 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 8: Moderate | 19 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 4: Good | 1 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 10: None | 20 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 4: Moderate | 15 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 8: Good | 8 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 4: None | 32 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 10: Moderate | 21 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 6: Good | 5 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 10: Good | 7 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 6: Moderate | 18 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 12: None | 19 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 12: Moderate | 20 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 2: Good | 0 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 6: None | 25 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 2: Moderate | 9 Participants |
| ILV-094 200 mg Every 2 Weeks | Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | Week 8: None | 21 Participants |
Comparison: Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.9Cochran-Mantel-Haenszel
Comparison: Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.522Cochran-Mantel-Haenszel
Comparison: Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.147Cochran-Mantel-Haenszel
Comparison: Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.534Cochran-Mantel-Haenszel
Comparison: Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.206Cochran-Mantel-Haenszel
Comparison: Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.07Cochran-Mantel-Haenszel
Comparison: Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.936Cochran-Mantel-Haenszel
Comparison: Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.625Cochran-Mantel-Haenszel
Comparison: Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.586Cochran-Mantel-Haenszel
Comparison: Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.685Cochran-Mantel-Haenszel
Comparison: Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.34Cochran-Mantel-Haenszel
Comparison: Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.212Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.455Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.145Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.66Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.05Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.428Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.16Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.757Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.408Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.983Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.374Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.992Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.422Cochran-Mantel-Haenszel
Comparison: Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.743Cochran-Mantel-Haenszel
Comparison: Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.188Cochran-Mantel-Haenszel
Comparison: Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.385Cochran-Mantel-Haenszel
Comparison: Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.148Cochran-Mantel-Haenszel
Comparison: Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.304Cochran-Mantel-Haenszel
Comparison: Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.552Cochran-Mantel-Haenszel
Comparison: Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.494Cochran-Mantel-Haenszel
Comparison: Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.421Cochran-Mantel-Haenszel
Comparison: Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.418Cochran-Mantel-Haenszel
Comparison: Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.235Cochran-Mantel-Haenszel
Comparison: Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.268Cochran-Mantel-Haenszel
Comparison: Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.p-value: 0.957Cochran-Mantel-Haenszel
Secondary
Pain Visual Analog Scale (VAS)
Participants assessed the amount of pain currently experienced by them on a 100 millimeter (mm) VAS ranging from 0= no pain to 100= severe pain.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Visual Analog Scale (VAS) | Baseline | 58.0 Millimeter | Standard Deviation 21.2 |
| Placebo | Pain Visual Analog Scale (VAS) | Week 10 | 45.2 Millimeter | Standard Deviation 26.1 |
| Placebo | Pain Visual Analog Scale (VAS) | Week 8 | 47.3 Millimeter | Standard Deviation 24.4 |
| Placebo | Pain Visual Analog Scale (VAS) | Week 2 | 49.8 Millimeter | Standard Deviation 23.5 |
| Placebo | Pain Visual Analog Scale (VAS) | Week 12 | 44.0 Millimeter | Standard Deviation 25 |
| Placebo | Pain Visual Analog Scale (VAS) | Week 4 | 46.8 Millimeter | Standard Deviation 23.7 |
| Placebo | Pain Visual Analog Scale (VAS) | Week 6 | 48.8 Millimeter | Standard Deviation 23.6 |
| ILV-094 100 mg Every 4 Weeks | Pain Visual Analog Scale (VAS) | Week 10 | 37.7 Millimeter | Standard Deviation 24.6 |
| ILV-094 100 mg Every 4 Weeks | Pain Visual Analog Scale (VAS) | Week 6 | 45.2 Millimeter | Standard Deviation 23.5 |
| ILV-094 100 mg Every 4 Weeks | Pain Visual Analog Scale (VAS) | Week 4 | 45.9 Millimeter | Standard Deviation 23.9 |
| ILV-094 100 mg Every 4 Weeks | Pain Visual Analog Scale (VAS) | Week 8 | 38.9 Millimeter | Standard Deviation 23.5 |
| ILV-094 100 mg Every 4 Weeks | Pain Visual Analog Scale (VAS) | Week 12 | 39.9 Millimeter | Standard Deviation 23.9 |
| ILV-094 100 mg Every 4 Weeks | Pain Visual Analog Scale (VAS) | Week 2 | 48.3 Millimeter | Standard Deviation 24 |
| ILV-094 100 mg Every 4 Weeks | Pain Visual Analog Scale (VAS) | Baseline | 56.0 Millimeter | Standard Deviation 19.1 |
| ILV-094 100 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Week 6 | 48.8 Millimeter | Standard Deviation 18.9 |
| ILV-094 100 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Baseline | 56.6 Millimeter | Standard Deviation 18.7 |
| ILV-094 100 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Week 2 | 51.7 Millimeter | Standard Deviation 23.7 |
| ILV-094 100 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Week 4 | 54.7 Millimeter | Standard Deviation 22 |
| ILV-094 100 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Week 8 | 49.0 Millimeter | Standard Deviation 22.8 |
| ILV-094 100 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Week 10 | 46.2 Millimeter | Standard Deviation 24 |
| ILV-094 100 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Week 12 | 44.9 Millimeter | Standard Deviation 22.4 |
| ILV-094 200 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Week 4 | 52.6 Millimeter | Standard Deviation 20.7 |
| ILV-094 200 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Week 12 | 42.6 Millimeter | Standard Deviation 19.9 |
| ILV-094 200 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Week 10 | 44.7 Millimeter | Standard Deviation 23.5 |
| ILV-094 200 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Week 2 | 52.3 Millimeter | Standard Deviation 21.5 |
| ILV-094 200 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Baseline | 56.5 Millimeter | Standard Deviation 23.6 |
| ILV-094 200 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Week 8 | 44.1 Millimeter | Standard Deviation 21.2 |
| ILV-094 200 mg Every 2 Weeks | Pain Visual Analog Scale (VAS) | Week 6 | 46.7 Millimeter | Standard Deviation 21.7 |
Secondary
Participant Global Assessment of Disease Activity
Participants answered: considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a scale ranging from 0 to 10, where 0 = no disease activity and 10 = extreme disease activity.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Participant Global Assessment of Disease Activity | Baseline | 6.2 Units on a scale | Standard Deviation 1.8 |
| Placebo | Participant Global Assessment of Disease Activity | Week 10 | 5.0 Units on a scale | Standard Deviation 2.3 |
| Placebo | Participant Global Assessment of Disease Activity | Week 8 | 5.1 Units on a scale | Standard Deviation 2.1 |
| Placebo | Participant Global Assessment of Disease Activity | Week 2 | 5.5 Units on a scale | Standard Deviation 2.3 |
| Placebo | Participant Global Assessment of Disease Activity | Week 12 | 4.7 Units on a scale | Standard Deviation 2.1 |
| Placebo | Participant Global Assessment of Disease Activity | Week 4 | 5.2 Units on a scale | Standard Deviation 2.1 |
| Placebo | Participant Global Assessment of Disease Activity | Week 6 | 5.0 Units on a scale | Standard Deviation 2 |
| ILV-094 100 mg Every 4 Weeks | Participant Global Assessment of Disease Activity | Week 10 | 4.0 Units on a scale | Standard Deviation 2.4 |
| ILV-094 100 mg Every 4 Weeks | Participant Global Assessment of Disease Activity | Week 6 | 4.7 Units on a scale | Standard Deviation 2.2 |
| ILV-094 100 mg Every 4 Weeks | Participant Global Assessment of Disease Activity | Week 4 | 5.0 Units on a scale | Standard Deviation 2.2 |
| ILV-094 100 mg Every 4 Weeks | Participant Global Assessment of Disease Activity | Week 8 | 4.6 Units on a scale | Standard Deviation 2.3 |
| ILV-094 100 mg Every 4 Weeks | Participant Global Assessment of Disease Activity | Week 12 | 4.5 Units on a scale | Standard Deviation 2.4 |
| ILV-094 100 mg Every 4 Weeks | Participant Global Assessment of Disease Activity | Week 2 | 5.5 Units on a scale | Standard Deviation 2.1 |
| ILV-094 100 mg Every 4 Weeks | Participant Global Assessment of Disease Activity | Baseline | 6.0 Units on a scale | Standard Deviation 1.8 |
| ILV-094 100 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Week 6 | 5.4 Units on a scale | Standard Deviation 1.8 |
| ILV-094 100 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Baseline | 6.3 Units on a scale | Standard Deviation 1.7 |
| ILV-094 100 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Week 2 | 5.6 Units on a scale | Standard Deviation 2.4 |
| ILV-094 100 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Week 4 | 5.6 Units on a scale | Standard Deviation 2.2 |
| ILV-094 100 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Week 8 | 5.5 Units on a scale | Standard Deviation 1.9 |
| ILV-094 100 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Week 10 | 5.2 Units on a scale | Standard Deviation 2.1 |
| ILV-094 100 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Week 12 | 5.0 Units on a scale | Standard Deviation 2 |
| ILV-094 200 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Week 4 | 5.5 Units on a scale | Standard Deviation 2 |
| ILV-094 200 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Week 12 | 4.8 Units on a scale | Standard Deviation 2.2 |
| ILV-094 200 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Week 10 | 5.0 Units on a scale | Standard Deviation 2.2 |
| ILV-094 200 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Week 2 | 5.7 Units on a scale | Standard Deviation 2.2 |
| ILV-094 200 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Baseline | 5.9 Units on a scale | Standard Deviation 2.1 |
| ILV-094 200 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Week 8 | 4.8 Units on a scale | Standard Deviation 2 |
| ILV-094 200 mg Every 2 Weeks | Participant Global Assessment of Disease Activity | Week 6 | 5.1 Units on a scale | Standard Deviation 2.1 |
Secondary
Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10
ACR20 response: \>=20 percent improvement in tender joint count; \>=20 percent improvement in swollen joint count; and \>=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).
Time frame: Week 2, 4, 6, 8, 10
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 8 | 31.8 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 4 | 24.2 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 10 | 42.4 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 6 | 33.3 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 2 | 18.2 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 6 | 46.2 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 8 | 48.7 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 10 | 56.4 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 4 | 33.3 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 2 | 17.9 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 6 | 23.8 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 2 | 14.3 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 4 | 21.4 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 8 | 33.3 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 10 | 42.9 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 8 | 35.4 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 4 | 27.1 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 2 | 14.6 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 6 | 39.6 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 | Week 10 | 31.3 Percentage of participants |
Comparison: Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.99195% CI: [-14.8, 14.7]Cochran-Mantel-Haenszel
Comparison: Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.51895% CI: [-18.4, 8.8]Cochran-Mantel-Haenszel
Comparison: Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.6395% CI: [-16.9, 9.8]Cochran-Mantel-Haenszel
Comparison: Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.29595% CI: [-8.3, 27]Cochran-Mantel-Haenszel
Comparison: Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.68695% CI: [-19.3, 12.5]Cochran-Mantel-Haenszel
Comparison: Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.77295% CI: [-13.2, 18.2]Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.20195% CI: [-6.5, 32]Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.25695% CI: [-27.3, 6.5]Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.51995% CI: [-11.4, 23.5]Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.09495% CI: [-1.9, 35.2]Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.7695% CI: [-14.4, 20.1]Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.9595% CI: [-16.8, 18]Cochran-Mantel-Haenszel
Comparison: Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.18595% CI: [-5.9, 33]Cochran-Mantel-Haenszel
Comparison: Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.98295% CI: [-18.8, 19.3]Cochran-Mantel-Haenszel
Comparison: Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.22395% CI: [-29, 5.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12
ACR50 response: \>=50 percent improvement in tender joint count; \>=50 percent improvement in swollen joint count; and 50 improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).
Time frame: Week 2, 4, 6, 8, 10, 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 2 | 3.0 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 4 | 6.1 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 6 | 9.1 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 8 | 7.6 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 10 | 18.2 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 12 | 15.2 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 12 | 23.1 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 8 | 12.8 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 2 | 2.6 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 6 | 7.7 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 4 | 7.7 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 10 | 17.9 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 4 | 7.1 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 6 | 14.3 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 8 | 4.8 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 12 | 14.3 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 10 | 9.5 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 2 | 9.5 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 10 | 18.8 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 12 | 14.6 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 4 | 4.2 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 8 | 14.6 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 2 | 0.0 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 | Week 6 | 12.5 Percentage of participants |
Comparison: Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.88595% CI: [-6.8, 5.8]Cochran-Mantel-Haenszel
Comparison: Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.1895% CI: [-3.4, 15.6]Cochran-Mantel-Haenszel
Comparison: Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.27795% CI: [-6.5, 1.1]Cochran-Mantel-Haenszel
Comparison: Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.7495% CI: [-7.9, 11.3]Cochran-Mantel-Haenszel
Comparison: Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.93495% CI: [-9.3, 10.1]Cochran-Mantel-Haenszel
Comparison: Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.87695% CI: [-7.7, 6.4]Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.84295% CI: [-11.4, 9.2]Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.50995% CI: [-8.1, 16.3]Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.50495% CI: [-7, 15]Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.37395% CI: [-6.3, 17]Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.49995% CI: [-12, 5.2]Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.24495% CI: [-4.2, 18.3]Cochran-Mantel-Haenszel
Comparison: Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.97995% CI: [-15, 14.6]Cochran-Mantel-Haenszel
Comparison: Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.16695% CI: [-21.8, 2.2]Cochran-Mantel-Haenszel
Comparison: Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.94795% CI: [-13.2, 14.2]Cochran-Mantel-Haenszel
Comparison: Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.28695% CI: [-7.1, 23.8]Cochran-Mantel-Haenszel
Comparison: Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.82295% CI: [-15, 11.8]Cochran-Mantel-Haenszel
Comparison: Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.98695% CI: [-12.3, 12.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12
ACR70 response:\>=70 percent improvement in tender joint count; \>=70 percent improvement in swollen joint count; and 70 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).
Time frame: Week 2, 4, 6, 8, 10, 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 2 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 4 | 1.5 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 6 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 8 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 10 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 12 | 4.5 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 12 | 5.1 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 8 | 2.6 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 2 | 2.6 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 6 | 2.6 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 4 | 2.6 Percentage of participants |
| ILV-094 100 mg Every 4 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 10 | 5.1 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 4 | 7.1 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 6 | 2.4 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 8 | 0.0 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 12 | 4.8 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 10 | 2.4 Percentage of participants |
| ILV-094 100 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 2 | 2.4 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 10 | 2.1 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 12 | 2.1 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 4 | 0.0 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 8 | 4.2 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 2 | 0.0 Percentage of participants |
| ILV-094 200 mg Every 2 Weeks | Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 | Week 6 | 2.1 Percentage of participants |
Comparison: Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.20595% CI: [-2.3, 7.4]Cochran-Mantel-Haenszel
Comparison: Week 2:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.18895% CI: [-2.3, 7.3]Cochran-Mantel-Haenszel
Comparison: Week 2: Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.95% CI: [0, 0]
Comparison: Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.69995% CI: [-4.5, 6.6]Cochran-Mantel-Haenszel
Comparison: Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.15595% CI: [-3, 13.8]Cochran-Mantel-Haenszel
Comparison: Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.54695% CI: [-2.9, 0.9]Cochran-Mantel-Haenszel
Comparison: Week 6:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.20595% CI: [-2.3, 7.4]Cochran-Mantel-Haenszel
Comparison: Week 6:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.26995% CI: [-1.8, 6.1]Cochran-Mantel-Haenszel
Comparison: Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.72395% CI: [-1.6, 5.6]Cochran-Mantel-Haenszel
Comparison: Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.20595% CI: [-2.3, 7.4]Cochran-Mantel-Haenszel
Comparison: Week 8: Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the cochran method.95% CI: [0, 0]
Comparison: Week 8:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.12595% CI: [-1.3, 9.4]Cochran-Mantel-Haenszel
Comparison: Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.07195% CI: [-1.7, 11.8]Cochran-Mantel-Haenszel
Comparison: Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.31795% CI: [-1.2, 5.1]Cochran-Mantel-Haenszel
Comparison: Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.2895% CI: [-1.6, 5.6]Cochran-Mantel-Haenszel
Comparison: Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.89295% CI: [-7.6, 8.8]Cochran-Mantel-Haenszel
Comparison: Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.90395% CI: [-8.3, 7.2]Cochran-Mantel-Haenszel
Comparison: Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.p-value: 0.62595% CI: [-7.2, 3.8]Cochran-Mantel-Haenszel
Secondary
Physician Global Assessment of Disease Activity
Physician global assessment of disease activity was measured on an 11-point scale, ranging from 0 to 10, where 0 = no disease activity and 10 = extreme disease activity.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Physician Global Assessment of Disease Activity | Baseline | 6.2 Units on a scale | Standard Deviation 1.6 |
| Placebo | Physician Global Assessment of Disease Activity | Week 10 | 4.2 Units on a scale | Standard Deviation 2.3 |
| Placebo | Physician Global Assessment of Disease Activity | Week 8 | 4.5 Units on a scale | Standard Deviation 2.1 |
| Placebo | Physician Global Assessment of Disease Activity | Week 2 | 5.4 Units on a scale | Standard Deviation 1.9 |
| Placebo | Physician Global Assessment of Disease Activity | Week 12 | 4.0 Units on a scale | Standard Deviation 2.2 |
| Placebo | Physician Global Assessment of Disease Activity | Week 4 | 4.7 Units on a scale | Standard Deviation 1.9 |
| Placebo | Physician Global Assessment of Disease Activity | Week 6 | 4.4 Units on a scale | Standard Deviation 1.8 |
| ILV-094 100 mg Every 4 Weeks | Physician Global Assessment of Disease Activity | Week 10 | 3.6 Units on a scale | Standard Deviation 1.7 |
| ILV-094 100 mg Every 4 Weeks | Physician Global Assessment of Disease Activity | Week 6 | 4.5 Units on a scale | Standard Deviation 1.9 |
| ILV-094 100 mg Every 4 Weeks | Physician Global Assessment of Disease Activity | Week 4 | 4.9 Units on a scale | Standard Deviation 1.8 |
| ILV-094 100 mg Every 4 Weeks | Physician Global Assessment of Disease Activity | Week 8 | 3.9 Units on a scale | Standard Deviation 1.6 |
| ILV-094 100 mg Every 4 Weeks | Physician Global Assessment of Disease Activity | Week 12 | 3.7 Units on a scale | Standard Deviation 2.1 |
| ILV-094 100 mg Every 4 Weeks | Physician Global Assessment of Disease Activity | Week 2 | 5.2 Units on a scale | Standard Deviation 1.8 |
| ILV-094 100 mg Every 4 Weeks | Physician Global Assessment of Disease Activity | Baseline | 6.3 Units on a scale | Standard Deviation 1.5 |
| ILV-094 100 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Week 6 | 4.3 Units on a scale | Standard Deviation 1.8 |
| ILV-094 100 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Baseline | 6.0 Units on a scale | Standard Deviation 1.7 |
| ILV-094 100 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Week 2 | 5.1 Units on a scale | Standard Deviation 2.1 |
| ILV-094 100 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Week 4 | 4.6 Units on a scale | Standard Deviation 2.2 |
| ILV-094 100 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Week 8 | 3.9 Units on a scale | Standard Deviation 1.9 |
| ILV-094 100 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Week 10 | 3.9 Units on a scale | Standard Deviation 1.9 |
| ILV-094 100 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Week 12 | 3.6 Units on a scale | Standard Deviation 1.9 |
| ILV-094 200 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Week 4 | 4.9 Units on a scale | Standard Deviation 1.9 |
| ILV-094 200 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Week 12 | 3.9 Units on a scale | Standard Deviation 2.1 |
| ILV-094 200 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Week 10 | 4.2 Units on a scale | Standard Deviation 2.3 |
| ILV-094 200 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Week 2 | 5.1 Units on a scale | Standard Deviation 1.7 |
| ILV-094 200 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Baseline | 6.0 Units on a scale | Standard Deviation 1.6 |
| ILV-094 200 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Week 8 | 4.1 Units on a scale | Standard Deviation 2 |
| ILV-094 200 mg Every 2 Weeks | Physician Global Assessment of Disease Activity | Week 6 | 4.3 Units on a scale | Standard Deviation 2 |
Secondary
Swollen Joints Count (SJC)
Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Swollen Joints Count (SJC) | Baseline | 10.2 Swollen joints | Standard Deviation 3.8 |
| Placebo | Swollen Joints Count (SJC) | Week 10 | 5.9 Swollen joints | Standard Deviation 5.8 |
| Placebo | Swollen Joints Count (SJC) | Week 8 | 6.4 Swollen joints | Standard Deviation 5.4 |
| Placebo | Swollen Joints Count (SJC) | Week 2 | 8.2 Swollen joints | Standard Deviation 5 |
| Placebo | Swollen Joints Count (SJC) | Week 12 | 5.5 Swollen joints | Standard Deviation 5.6 |
| Placebo | Swollen Joints Count (SJC) | Week 4 | 7.0 Swollen joints | Standard Deviation 4.9 |
| Placebo | Swollen Joints Count (SJC) | Week 6 | 6.6 Swollen joints | Standard Deviation 5.3 |
| ILV-094 100 mg Every 4 Weeks | Swollen Joints Count (SJC) | Week 10 | 5.4 Swollen joints | Standard Deviation 5.5 |
| ILV-094 100 mg Every 4 Weeks | Swollen Joints Count (SJC) | Week 6 | 5.7 Swollen joints | Standard Deviation 5.4 |
| ILV-094 100 mg Every 4 Weeks | Swollen Joints Count (SJC) | Week 4 | 6.8 Swollen joints | Standard Deviation 5.1 |
| ILV-094 100 mg Every 4 Weeks | Swollen Joints Count (SJC) | Week 8 | 6.0 Swollen joints | Standard Deviation 6 |
| ILV-094 100 mg Every 4 Weeks | Swollen Joints Count (SJC) | Week 12 | 5.6 Swollen joints | Standard Deviation 5.9 |
| ILV-094 100 mg Every 4 Weeks | Swollen Joints Count (SJC) | Week 2 | 8.4 Swollen joints | Standard Deviation 5.2 |
| ILV-094 100 mg Every 4 Weeks | Swollen Joints Count (SJC) | Baseline | 10.0 Swollen joints | Standard Deviation 4.6 |
| ILV-094 100 mg Every 2 Weeks | Swollen Joints Count (SJC) | Week 6 | 6.0 Swollen joints | Standard Deviation 5.8 |
| ILV-094 100 mg Every 2 Weeks | Swollen Joints Count (SJC) | Baseline | 9.4 Swollen joints | Standard Deviation 4.6 |
| ILV-094 100 mg Every 2 Weeks | Swollen Joints Count (SJC) | Week 2 | 6.9 Swollen joints | Standard Deviation 5.2 |
| ILV-094 100 mg Every 2 Weeks | Swollen Joints Count (SJC) | Week 4 | 5.8 Swollen joints | Standard Deviation 5 |
| ILV-094 100 mg Every 2 Weeks | Swollen Joints Count (SJC) | Week 8 | 5.0 Swollen joints | Standard Deviation 4.9 |
| ILV-094 100 mg Every 2 Weeks | Swollen Joints Count (SJC) | Week 10 | 5.2 Swollen joints | Standard Deviation 5.2 |
| ILV-094 100 mg Every 2 Weeks | Swollen Joints Count (SJC) | Week 12 | 5.0 Swollen joints | Standard Deviation 5.3 |
| ILV-094 200 mg Every 2 Weeks | Swollen Joints Count (SJC) | Week 4 | 7.0 Swollen joints | Standard Deviation 5 |
| ILV-094 200 mg Every 2 Weeks | Swollen Joints Count (SJC) | Week 12 | 5.5 Swollen joints | Standard Deviation 5.9 |
| ILV-094 200 mg Every 2 Weeks | Swollen Joints Count (SJC) | Week 10 | 5.9 Swollen joints | Standard Deviation 5.8 |
| ILV-094 200 mg Every 2 Weeks | Swollen Joints Count (SJC) | Week 2 | 8.0 Swollen joints | Standard Deviation 4.7 |
| ILV-094 200 mg Every 2 Weeks | Swollen Joints Count (SJC) | Baseline | 10.0 Swollen joints | Standard Deviation 4.1 |
| ILV-094 200 mg Every 2 Weeks | Swollen Joints Count (SJC) | Week 8 | 5.6 Swollen joints | Standard Deviation 5.2 |
| ILV-094 200 mg Every 2 Weeks | Swollen Joints Count (SJC) | Week 6 | 5.9 Swollen joints | Standard Deviation 5.1 |
Secondary
Tender Joints Counts (TJC)
Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 12
Population: mITT population included all randomized participants who received at least 1 dose of study drug. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Tender Joints Counts (TJC) | Week 10 | 8.4 Tender joints | Standard Deviation 7 |
| Placebo | Tender Joints Counts (TJC) | Baseline | 13.4 Tender joints | Standard Deviation 5.2 |
| Placebo | Tender Joints Counts (TJC) | Week 2 | 11.1 Tender joints | Standard Deviation 6 |
| Placebo | Tender Joints Counts (TJC) | Week 4 | 10.4 Tender joints | Standard Deviation 6.6 |
| Placebo | Tender Joints Counts (TJC) | Week 6 | 9.5 Tender joints | Standard Deviation 7.1 |
| Placebo | Tender Joints Counts (TJC) | Week 8 | 9.2 Tender joints | Standard Deviation 7.2 |
| Placebo | Tender Joints Counts (TJC) | Week 12 | 7.7 Tender joints | Standard Deviation 6.4 |
| ILV-094 100 mg Every 4 Weeks | Tender Joints Counts (TJC) | Week 12 | 7.4 Tender joints | Standard Deviation 8 |
| ILV-094 100 mg Every 4 Weeks | Tender Joints Counts (TJC) | Week 6 | 8.1 Tender joints | Standard Deviation 7.5 |
| ILV-094 100 mg Every 4 Weeks | Tender Joints Counts (TJC) | Week 10 | 7.2 Tender joints | Standard Deviation 6.9 |
| ILV-094 100 mg Every 4 Weeks | Tender Joints Counts (TJC) | Week 4 | 9.5 Tender joints | Standard Deviation 7.1 |
| ILV-094 100 mg Every 4 Weeks | Tender Joints Counts (TJC) | Baseline | 13.2 Tender joints | Standard Deviation 6.3 |
| ILV-094 100 mg Every 4 Weeks | Tender Joints Counts (TJC) | Week 8 | 7.8 Tender joints | Standard Deviation 7.2 |
| ILV-094 100 mg Every 4 Weeks | Tender Joints Counts (TJC) | Week 2 | 10.9 Tender joints | Standard Deviation 7.1 |
| ILV-094 100 mg Every 2 Weeks | Tender Joints Counts (TJC) | Week 8 | 7.9 Tender joints | Standard Deviation 7.2 |
| ILV-094 100 mg Every 2 Weeks | Tender Joints Counts (TJC) | Week 10 | 8.0 Tender joints | Standard Deviation 7.1 |
| ILV-094 100 mg Every 2 Weeks | Tender Joints Counts (TJC) | Baseline | 12.3 Tender joints | Standard Deviation 5.9 |
| ILV-094 100 mg Every 2 Weeks | Tender Joints Counts (TJC) | Week 2 | 10.8 Tender joints | Standard Deviation 7.8 |
| ILV-094 100 mg Every 2 Weeks | Tender Joints Counts (TJC) | Week 6 | 9.2 Tender joints | Standard Deviation 7.8 |
| ILV-094 100 mg Every 2 Weeks | Tender Joints Counts (TJC) | Week 12 | 7.8 Tender joints | Standard Deviation 7.7 |
| ILV-094 100 mg Every 2 Weeks | Tender Joints Counts (TJC) | Week 4 | 9.5 Tender joints | Standard Deviation 6.7 |
| ILV-094 200 mg Every 2 Weeks | Tender Joints Counts (TJC) | Week 10 | 9.5 Tender joints | Standard Deviation 7 |
| ILV-094 200 mg Every 2 Weeks | Tender Joints Counts (TJC) | Week 2 | 12.5 Tender joints | Standard Deviation 6.4 |
| ILV-094 200 mg Every 2 Weeks | Tender Joints Counts (TJC) | Week 12 | 9.2 Tender joints | Standard Deviation 7 |
| ILV-094 200 mg Every 2 Weeks | Tender Joints Counts (TJC) | Week 4 | 11.2 Tender joints | Standard Deviation 6.5 |
| ILV-094 200 mg Every 2 Weeks | Tender Joints Counts (TJC) | Week 6 | 9.3 Tender joints | Standard Deviation 6.4 |
| ILV-094 200 mg Every 2 Weeks | Tender Joints Counts (TJC) | Week 8 | 9.3 Tender joints | Standard Deviation 6.6 |
| ILV-094 200 mg Every 2 Weeks | Tender Joints Counts (TJC) | Baseline | 14.4 Tender joints | Standard Deviation 5.9 |