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)

Psoriatic Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427362
• Other study ID #: W05-399
• Secondary ID: ACCLAIM
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2007
• Last updated: April 30, 2008
• Start date: May 2006

Study information

• Verified date: April 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Adalimumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20 response		Week 12
Secondary	ACR50		Week 12
Secondary	ACR70		Week 12
Secondary	PsARC		Week 12
Secondary	DAS28		Week 12
Secondary	PASI50/75		Week 12
Secondary	HAQ-DI		Week 12
Secondary	PsAQoL		Week 12