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

Use our guide to learn which trials are right for you!

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
sites
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Aventura, FL
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
?
mi
from
Eagan, MN
Click here to add this to my saved trials
?
mi
from
Florissant, MO
Click here to add this to my saved trials
?
mi
from
Flowood, MS
Click here to add this to my saved trials
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
?
mi
from
Hagerstown, MD
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orange Park, FL
Click here to add this to my saved trials
?
mi
from
Palm Desert, CA
Click here to add this to my saved trials
?
mi
from
Peoria, AZ
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Tuscaloosa, AL
Click here to add this to my saved trials
?
mi
from
Vero Beach, FL
Click here to add this to my saved trials