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

Primary outcomes

1. 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.

2. 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.

3. 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.

4. Inflammatory Parameter: Change From Baseline in CRP Over Time

   Time frame: Baseline, Months 3, 6, 12, 24, 60

5. Inflammatory Parameter: Change From Baseline in ESR Over Time

   Time frame: Baseline, Months 3, 6, 12, 24, 60

6. 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.

7. 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.

8. 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.

9. BSA With PsA Over Time: PsA Participants

   Time frame: Baseline, Months 3, 6, 12, 24, 60

10. 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.

11. 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.

12. 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.

13. 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.