A Belgian Registry of HUMIRA® (Adalimumab) in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis ( ProAct ) (ProAct)

A Five Year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis or Psoriatic Arthritis Who Are Treated With HUMIRA (Adalimumab)

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).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis

• Study Type: Observational
• Enrollment (Actual): 5940

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Rheumatologists

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with rheumatic disease; Patients suffering from rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Physician's Assessment of Disease Activity Over Time	Physician's assessment of disease activity is measured on a visual analogue scale (VAS) from 0 to 100, with the highest values indicating the worst disease activity.	Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in Tender Joints Over Time	A total of 28 joints were assessed for tenderness.	Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in Swollen Joints Over Time	A total of 28 joints were assessed for swelling.	Baseline, Months 3, 6, 12, 24, 60
Inflammatory Parameter: Change From Baseline in CRP Over Time		Baseline, Months 3, 6, 12, 24, 60
Inflammatory Parameter: Change From Baseline in ESR Over Time		Baseline, Months 3, 6, 12, 24, 60
Physical Function: Change From Baseline in HAQ% Over Time	The HAQ score measures quality of life in terms of physical function and consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 7 days using the following responses: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). In the classical HAQ questionnaire, the potential maximum score (60) indicates the most severe disability and the minimum score (0) indicates no disability. The HAQ% is a typical 'Belgian scoring method,' where the actual total score on 60 is converted to a percentage. The HAQ% is performed by all Belgian rheumatologists and is required for obtaining reimbursement.	Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in DAS28 Over Time: RA Participants	The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline, Months 3, 6, 12, 24, 60
DAS28 Category Over Time: RA Participants	The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline, Months 3, 6, 12, 24, 60
BSA With PsA Over Time: PsA Participants		Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants	Participants used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days.	Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants	Physicians used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days.	Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in BASDAI Over Time: AS Participants	BASDAI score measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness, and is calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe). The final BASDAI score ranges from 0 to 10 with higher score indicating more severe symptoms.	Baseline, Months 3, 6, 12, 24, 60
Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation	An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An SAE is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.	up to 60 months

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborators: Veeda Clinical Research

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2004
• Primary Completion (Actual): January 11, 2018
• Study Completion (Actual): January 11, 2018

Study Registration Dates

• First Submitted: March 1, 2010
• First Submitted That Met QC Criteria: March 1, 2010
• First Posted (Estimate): March 2, 2010

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Multicenter study
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Psoriasis; Bone Diseases, Infectious; Ankylosis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: HUM04-28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No