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

NCT01078558 | Completed Results

• 1 other identifier: HUM04-28
• Study Type: observational
• Target: 5,940
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis

Keywords

Multicenter study

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (1)

Patients with rheumatic disease

Patients suffering from rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Rheumatologists

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Veeda Clinical Research: collaborator

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: May 13, 2004
• Primary Completion: January 11, 2018
• Study Completion: January 11, 2018
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2018-11