Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

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).

Key facts

Study ID

NCT01087788

Run by

UCB BIOSCIENCES GmbH

People needed

409

Starts

2010-03-01

Expected to finish

2015-08-01

Last updated by the study team

2018-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Erythrocyte Sedimentation Rate (ESR) (Westergren) ≥ 28 mm/hour
• C-reactive protein (CRP) > Upper Limit Normal (ULN)
• Failure to 1 or more treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

You may not qualify if…

• 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

Where it is running

• 953 — Tuscaloosa, Alabama, United States
• 954 — Peoria, Arizona, United States
• 971 — Scottsdale, Arizona, United States
• 966 — Palm Desert, California, United States
• 952 — San Diego, California, United States
• 957 — Aventura, Florida, United States
• 962 — Fort Lauderdale, Florida, United States
• 959 — Orange Park, Florida, United States
• 958 — Vero Beach, Florida, United States
• 964 — Hagerstown, Maryland, United States
• 960 — Kalamazoo, Michigan, United States
• 969 — Eagan, Minnesota, United States
• 984 — Flowood, Mississippi, United States
• 965 — Florissant, Missouri, United States
• 950 — St Louis, Missouri, United States
• 985 — Brooklyn, New York, United States
• 963 — Asheville, North Carolina, United States
• 976 — Cleveland, Ohio, United States
• 951 — Middleburg Heights, Ohio, United States
• 970 — Oklahoma City, Oklahoma, United States
• 982 — Portland, Oregon, United States
• 972 — Duncansville, Pennsylvania, United States
• 975 — Dallas, Texas, United States
• 978 — Houston, Texas, United States
• 961 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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