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

Rheumatoid Arthritis Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078558
• Other study ID #: HUM04-28
• Status: Completed
• Start date: May 13, 2004
• Est. completion date: January 11, 2018

Study information

• Verified date: November 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5940
• Est. completion date: January 11, 2018
• Est. primary completion date: January 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Veeda Clinical Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change From Baseline in Tender Joints Over Time	A total of 28 joints were assessed for tenderness.	Baseline, Months 3, 6, 12, 24, 60
Primary	Change From Baseline in Swollen Joints Over Time	A total of 28 joints were assessed for swelling.	Baseline, Months 3, 6, 12, 24, 60
Primary	Inflammatory Parameter: Change From Baseline in CRP Over Time		Baseline, Months 3, 6, 12, 24, 60
Primary	Inflammatory Parameter: Change From Baseline in ESR Over Time		Baseline, Months 3, 6, 12, 24, 60
Primary	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
Primary	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
Primary	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
Primary	BSA With PsA Over Time: PsA Participants		Baseline, Months 3, 6, 12, 24, 60
Primary	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
Primary	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
Primary	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
Primary	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

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