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

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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).


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
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Hagerstown, MD
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Asheville, NC
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Birmingham, AL
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Buenos Aires,
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Cleveland, OH
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Dallas, TX
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Duncansville, Pennsylvania 16635
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Eagan, MN
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Florissant, MO
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Flowood, MS
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Fort Lauderdale, FL
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Houston, TX
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Middleburg Heights, OH
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Oklahoma City, OK
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Portland, OR
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Saint Louis, MO
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Tuscaloosa, AL
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2261
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Vero Beach, FL
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