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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Adalimumab

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Benoit Guerette, PhD

Role: STUDY_DIRECTOR

Abbott

References

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Gladman DD; ACCLAIM Study Investigators; Sampalis JS, Illouz O, Guerette B. Responses to adalimumab in patients with active psoriatic arthritis who have not adequately responded to prior therapy: effectiveness and safety results from an open-label study. J Rheumatol. 2010 Sep;37(9):1898-906. doi: 10.3899/jrheum.100069. Epub 2010 Jul 1.

Reference Type DERIVED

PMID: 20595284 (View on PubMed)

Other Identifiers

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ACCLAIM

Identifier Type: -

Identifier Source: secondary_id

W05-399