Clinical trial NCT01078558: A Belgian Registry of HUMIRA® (Adalimumab) in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis ( ProAct )
Official title: A Five Year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis or Psoriatic Arthritis Who Are Treated With HUMIRA (Adalimumab)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Keywords: Multicenter study
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Veeda Clinical Research
First posted: 2010-03-02
Enrollment: 5940
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rheumatologists

Brief summary: This is a five year, post-marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA (adalimumab).


Eligibility criteria: Inclusion Criteria:

* Patients with ongoing HUMIRA (adalimumab) treatment who have been prescribed HUMIRA (adalimumab) within local reimbursement guidelines.
* Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

Exclusion Criteria:

* Contraindications according to the summary of product characteristics.
* Patients who are actually followed in the ReAlise registry (M03-634 NCT00234884).

Primary outcomes:
measure: Change From Baseline in Physician's Assessment of Disease Activity Over Time
timeFrame: Baseline, Months 3, 6, 12, 24, 60
measure: Change From Baseline in Tender Joints Over Time
timeFrame: Baseline, Months 3, 6, 12, 24, 60
measure: Change From Baseline in Swollen Joints Over Time
timeFrame: Baseline, Months 3, 6, 12, 24, 60
measure: Inflammatory Parameter: Change From Baseline in CRP Over Time
timeFrame: Baseline, Months 3, 6, 12, 24, 60
measure: Inflammatory Parameter: Change From Baseline in ESR Over Time
timeFrame: Baseline, Months 3, 6, 12, 24, 60
measure: Physical Function: Change From Baseline in HAQ% Over Time
timeFrame: Baseline, Months 3, 6, 12, 24, 60
measure: Change From Baseline in DAS28 Over Time: RA Participants
timeFrame: Baseline, Months 3, 6, 12, 24, 60
measure: DAS28 Category Over Time: RA Participants
timeFrame: Baseline, Months 3, 6, 12, 24, 60
measure: BSA With PsA Over Time: PsA Participants
timeFrame: Baseline, Months 3, 6, 12, 24, 60
measure: Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants
timeFrame: Baseline, Months 3, 6, 12, 24, 60
measure: Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants
timeFrame: Baseline, Months 3, 6, 12, 24, 60
measure: Change From Baseline in BASDAI Over Time: AS Participants
timeFrame: Baseline, Months 3, 6, 12, 24, 60
measure: Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation
timeFrame: up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: