Phase 2
Completed N=195
Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00883896 ↗Enrolled (actual)
195
Serious AEs
4.6%
Results posted
Oct 2022
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12 — 50.0; 43.6; 38.1; 50.0 Percentage of participants — p=0.558
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12 |
50.0; 43.6; 38.1; 50.0 | 0.558 |
| SECONDARY Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 |
18.2; 17.9; 14.3; 14.6; 24.2; 33.3 | 0.991 |
| SECONDARY Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 |
3.0; 2.6; 9.5; 0.0; 6.1; 7.7 | 0.885 |
| SECONDARY Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 |
0.0; 2.6; 2.4; 0.0; 1.5; 2.6 | 0.205 |
| SECONDARY Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) |
5.6; 5.5; 5.3; 5.5; 5.1; 5.1 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) |
6.4; 6.4; 6.2; 6.3; 5.8; 5.9 | — |
| SECONDARY Tender Joints Counts (TJC) |
13.4; 13.2; 12.3; 14.4; 11.1; 10.9 | — |
| SECONDARY Swollen Joints Count (SJC) |
10.2; 10.0; 9.4; 10.0; 8.2; 8.4 | — |
| SECONDARY Physician Global Assessment of Disease Activity |
6.2; 6.3; 6.0; 6.0; 5.4; 5.2 | — |
| SECONDARY Participant Global Assessment of Disease Activity |
6.2; 6.0; 6.3; 5.9; 5.5; 5.5 | — |
| SECONDARY Pain Visual Analog Scale (VAS) |
58.0; 56.0; 56.6; 56.5; 49.8; 48.3 | — |
| SECONDARY General Health Visual Analog Scale (VAS) |
60.8; 59.2; 61.0; 57.7; 54.1; 52.5 | — |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |
1.4; 1.3; 1.3; 1.3; 1.3; 1.3 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) |
33.8; 34.9; 34.8; 34.4; 40.5; 42.0 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale |
29.1; 30.9; 30.6; 29.2; 31.7; 33.6 | — |
| SECONDARY Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 |
3; 1; 5; 0; 15; 10 | 0.900 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00883896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.