Clinical trial · Interventional
Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy
- 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 purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who have had an inadequate response to anti-tumor necrosis factor (anti-TNF) therapy.
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 |
|---|---|---|---|
| CDP6038 | Biological | — | UNRESOLVED |
| Placebo iv | Other | — | UNRESOLVED |
| Placebo sc | Other | — | UNRESOLVED |
| Tocilizumab (Actemra or RoActemra) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- CDP6038 60 mg sc every 2 weeks plus methotrexate
- interventionNames
- Biological: CDP6038
- Other: Placebo iv
- type
- EXPERIMENTAL
- label
- CDP6038 60 mg sc every 4 weeks plus methotrexate
- interventionNames
- Biological: CDP6038
- Other: Placebo sc
- Other: Placebo iv
- type
- EXPERIMENTAL
- label
- CDP6038 120 mg sc every 2 weeks plus methotrexate
- interventionNames
- Biological: CDP6038
- Other: Placebo iv
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a diagnosis of rheumatoid arthritis (according to the 1987 ACR classification criteria OR a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for rheumatoid arthritis ) for at least 6 months prior to screening * Must have been treated with MTX 12.5-25 mg/week, for at least 6 weeks prior to screening. Doses of 10 to \< 12.5mg/week are allowed if there is documented intolerance * Have moderately to severely active rheumatoid arthritis disease with at least 6 tender and 6 swollen joints * CRP ≥1.2 times the upper limit of normal (central laboratory) or erythrocyte sedimentation rate of more than 28mm/hour * Intolerant or inadequate response to treatment (ie, TNF blocker failure)≥1 licensed TNF-blocker therapies within 2 years of screening Exclusion Criteria: * Have a diagnosis of any other inflammatory arthritis or secondary, noninflammatory type of arthritis, such as psoriatic arthritis, lupus, gout, or ankylosing spondylitis * Wheelchair bound or bedridden. * Disease modifying antirheumatic drugs (DMARDs) other than MTX. * Treatment with tocilizumab or any other anti-IL-6 investigational therapies at any time. * Treatment with other biologics within 4-24 weeks (depending on the biologic) * History of ongoing, chronic or recurrent infections or recent serious or life-threatening infection * Known concurrent acute or chronic viral hepatitis B or C infection or human immunodeficiency virus (HIV) infection. * Vaccinations (other than injectable influenza or pneumococcal) within 8 weeks prior to screening or plan to receive vaccines during the study * Concurrent or history of malignancy with the exception of nonmelanoma skin cancer successfully treated more than 2 years prior to screening or cervical cancer successfully treated more than 5 years prior to screening. * History of chronic alcohol abuse or drug addiction within the last 1 year or current drug addiction or use of illicit drugs.
References
Publications (1)
- DERIVEDGenovese MC, Fleischmann R, Furst D, Janssen N, Carter J, Dasgupta B, Bryson J, Duncan B, Zhu W, Pitzalis C, Durez P, Kretsos K. Efficacy and safety of olokizumab in patients with rheumatoid arthritis with an inadequate response to TNF inhibitor therapy: outcomes of a randomised Phase IIb study. Ann Rheum Dis. 2014 Sep;73(9):1607-15. doi: 10.1136/annrheumdis-2013-204760. Epub 2014 Mar 18. PMID 24641941