Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/3/2018 |
Start Date: | March 2010 |
End Date: | August 2015 |
Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Adult-Onset Active and Progressive Psoriatic Arthritis (PsA)
Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to
evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset
active and progressive Psoriatic Arthritis (PsA).
evaluate the efficacy and safety of Certolizumab Pegol (CZP) in subjects with adult onset
active and progressive Psoriatic Arthritis (PsA).
Inclusion Criteria:
- Diagnosis of adult-onset Psoriatic Arthritis (PsA) of at least 6 months' duration as
defined by the Classification Criteria for Psoriatic Arthritis (CASPAR criteria)
- Active Psoriatic Skin Lesions or a documented history of Psoriasis
- Active Arthritis with ≥ 3 tender joints at Screening and Baseline, ≥ 3 swollen joints
at Screening and Baseline and fulfilling at least 1 of the following 2 criteria during
the Screening Period:
1. Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hour
2. C-reactive protein (CRP) > Upper Limit Normal (ULN)
- Failure to 1 or more treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Exclusion Criteria:
- Diagnosis of any other inflammatory Arthritis or known diagnosis of Fibromyalgia
- Exposure to more than 1 Tumor Necrosis Factor α (TNFα) antagonist or to more than 2
previous biological response modifiers for PsA or Psoriasis
- Any non-biological systemic treatment of Psoriasis; phototherapy; topical agents
- History of chronic or recurrent infections
- High risk of infection
- Live vaccination within the 8 weeks prior to Baseline
- Concurrent malignancy or a history of malignancy
- Class III or IV congestive Heart Failure - New York Heart Association (NYHA)
- Demyelinating disease of the central nervous system
- Clinically significant laboratory abnormalities
We found this trial at
28
sites
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