A Canadian Open-Label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriatic Arthritis (PsA) (ACCLAIM) - Full Text View

A Canadian Open-Label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriatic Arthritis (PsA) (ACCLAIM)

This study has been completed.

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00427362

Purpose

To further assess the safety and effectiveness of adalimumab 40mg in the treatment PsA who have had an unsatisfactory response or intolerance to prior or ongoing DMARDs

Condition	Intervention	Phase
Psoriatic Arthritis	Drug: Adalimumab	Phase III

ChemIDplus related topics:

Adalimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Canadian Open-Label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriatic Arthritis (PsA) (ACCLAIM)

Further study details as provided by Abbott:

Primary Outcome Measures:

ACR20 response [ Time Frame: Week 12 ]

Secondary Outcome Measures:

ACR50 [ Time Frame: Week 12 ]
ACR70 [ Time Frame: Week 12 ]
PsARC [ Time Frame: Week 12 ]
DAS28 [ Time Frame: Week 12 ]
PASI50/75 [ Time Frame: Week 12 ]
HAQ-DI [ Time Frame: Week 12 ]
PsAQoL [ Time Frame: Week 12 ]

Enrollment:	127
Study Start Date:	May 2006
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Active psoriatic arthritis defined by >= 3 tender or painful joints and >= 3 swollen joints despite standard psoriatic arthritis therapy
Has had an unsatisfactory response or intolerance to at least two prior or ongoing DMARDs (one of which has to be methotrexate)

Exclusion Criteria:

Has a history of cancer or other than certain skin or cervical cancers
Has a history of, or current acute inflammatory joint disease of origin other than PsA, e.g., systemic lupus erythematosus etc.
Has other, unstable diseases, including congestive heart failure, inflammatory bowel disease, recent stroke, leg ulcers or other condition which would put the subject at risk
History of active tuberculosis, history of histoplasmosis or listeriosis
Latent TB or risk factors for the activation of latent TB, e.g. previous exposure to TB, and has not initiated TB prophylaxis prior to the first adalimumab treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427362

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Benoit Guerette, PhD	Abbott

More Information

Study ID Numbers:	W05-399, ACCLAIM
First Received:	January 26, 2007
Last Updated:	April 30, 2008
ClinicalTrials.gov Identifier:	NCT00427362
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Spinal Diseases

Skin Diseases

Arthritis, Psoriatic

Joint Diseases

Spondylarthropathy

Adalimumab

Bone Diseases

Musculoskeletal Diseases

Psoriasis

Arthritis

Spondylarthritis

Skin Diseases, Papulosquamous

Spondylarthropathies

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Therapeutic Uses

Antirheumatic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008