Clinical trial · Interventional
Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy
A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy
NCT01463059CI-TRIAL-00009807completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olokizumab 120 mg | Biological | — | UNRESOLVED |
| Olokizumab 240 mg | Biological | — | UNRESOLVED |
| Olokizumab 60 mg | Biological | — | UNRESOLVED |
| Placebo | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- PLACEBO_COMPARATOR
- label
- Placebo every 2 weeks
- description
- Injections administered at week 0, 2, 4, 6, 8 and 10
- interventionNames
- Biological: Placebo
- type
- EXPERIMENTAL
- label
- Olokizumab 60 mg every 2 weeks
- description
- Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10
- interventionNames
- Biological: Olokizumab 60 mg
- type
- EXPERIMENTAL
- label
- Olokizumab 60 mg every 4 weeks
- description
- Olokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Have a diagnosis of adult-onset RA of at least 6 months' (24 weeks) duration as defined by the 1987 ACR classification criteria or a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA * Must have moderately to severely active RA disease as defined by ≥6 tender joints (68-joint count) at Screening and Baseline, ≥6 swollen joints (66-joint count) at Screening and Baseline, CRP ≥1.2 times the upper limit of normal (ULN) or ESR \>28mm/hour * Must be on an MTX dose of 6 to 16mg/week in Japan or 7.5 to 20mg/week in Korea and Taiwan, which has been stable for at least 6 weeks prior to Screening with a stable route of administration * Must have had intolerance or inadequate response to treatment with 1 or more TNF-blocker therapies within 2 years of Screening * Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception Exclusion Criteria: * Have a diagnosis of any other inflammatory arthritis * Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks * Disease modifying antirheumatic drug (DMARDs) other than methotrexate (MTX) * Subjects with known concurrent acute or chronic viral hepatitis B or C infection * Subject has known tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection * Subjects with known history of or current clinically active infection * Subjects at high risk of infection * Subjects with known human immunodeficiency virus (HIV) or human T cell lymphotropic virus type 1 (HTLV 1) infection * Have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted) * Concurrent malignancy or a history of malignancy (with the exception of successfully treated carcinoma of the cervix more than 5 years prior to Screening or no more than 2 successfully treated basal cell carcinomas within 2 years prior to Screening
References
Publications (1)
- DERIVEDTakeuchi T, Tanaka Y, Yamanaka H, Amano K, Nagamine R, Park W, Shiozawa K, Tsukano M, Wei JC, Shao J, Togo O, Mashimo H. Efficacy and safety of olokizumab in Asian patients with moderate-to-severe rheumatoid arthritis, previously exposed to anti-TNF therapy: Results from a randomized phase II trial. Mod Rheumatol. 2016;26(1):15-23. doi: 10.3109/14397595.2015.1074648. Epub 2015 Sep 10. PMID 26358841