A Five Year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis or Psoriatic Arthritis Who Are Treated With HUMIRA (Adalimumab)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Enrollment
- 5940
- Primary Endpoint
- Change From Baseline in Swollen Joints Over Time
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
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).
Outcomes
Primary Outcomes
Change From Baseline in Swollen Joints Over Time
Time Frame: Baseline, Months 3, 6, 12, 24, 60
A total of 28 joints were assessed for swelling.
Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants
Time Frame: Baseline, Months 3, 6, 12, 24, 60
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.
Change From Baseline in Physician's Assessment of Disease Activity Over Time
Time Frame: Baseline, Months 3, 6, 12, 24, 60
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.
Inflammatory Parameter: Change From Baseline in CRP Over Time
Time Frame: Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in DAS28 Over Time: RA Participants
Time Frame: Baseline, Months 3, 6, 12, 24, 60
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.
Change From Baseline in Tender Joints Over Time
Time Frame: Baseline, Months 3, 6, 12, 24, 60
A total of 28 joints were assessed for tenderness.
Inflammatory Parameter: Change From Baseline in ESR Over Time
Time Frame: Baseline, Months 3, 6, 12, 24, 60
Physical Function: Change From Baseline in HAQ% Over Time
Time Frame: Baseline, Months 3, 6, 12, 24, 60
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.
DAS28 Category Over Time: RA Participants
Time Frame: Baseline, Months 3, 6, 12, 24, 60
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.
Change From Baseline in BASDAI Over Time: AS Participants
Time Frame: Baseline, Months 3, 6, 12, 24, 60
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.
BSA With PsA Over Time: PsA Participants
Time Frame: Baseline, Months 3, 6, 12, 24, 60
Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants
Time Frame: Baseline, Months 3, 6, 12, 24, 60
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.
Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation
Time Frame: up to 60 months
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.