Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Monoclonal Antibody, Interleukin-6, Olokizumab, CDP6038
Brief summary
The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo.
Interventions
BIOLOGICALPlacebo
Placebo solution for injection, administered as subcutaneous injections
BIOLOGICALOlokizumab 60 mg
Olokizumab 60 mg solution for injection, administered as subcutaneous injections
BIOLOGICALOlokizumab 120 mg
Olokizumab 120 mg solution for injection, administered as subcutaneous injections
BIOLOGICALOlokizumab 240 mg
Olokizumab 240 mg solution for injection, administered as subcutaneous injections
Sponsors
UCB Japan Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 12 | From Week 0 (Baseline) to Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 12 | From Week 0 (Baseline) to Week 12 | Number of subjects who achieve ACR 20 will be calculated at week 12. The calculation is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards. |
| Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 12 | From Week 0 (Baseline) to Week 12 | Number of subjects who achieve ACR 50 will be calculated at week 12. The calculation is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards. |
| Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 12 | From Week 0 (Baseline) to Week 12 | Number of subjects who achieve ACR 70 will be calculated at week 12. The calculations is based on the improvement from the baseline in the number of tender joints and in the number of swollen joints each; and the improvement based on assessments from the patient and the physician drawn according to defined standards. |
Countries
Japan, South Korea, Taiwan
Outcome results
None listed