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

This study is ongoing, but not recruiting participants.
Veeda Clinical Research
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
First received: March 1, 2010
Last updated: April 28, 2016
Last verified: April 2016
This 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).

Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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)

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Swollen and tender joint count, C reactive protein, Erythrocyte sedimentation rate, Health assessment questionnaire, Body surface area with psoriasis, numerical rating scale, Bath ankylosing spondylitis disease activity index, concomitant medication [ Time Frame: 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months ] [ Designated as safety issue: No ]
  • Safety parameters/ SAE reporting [ Time Frame: 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5914
Study Start Date: May 2004
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Patients with rheumatic disease
Patients suffering from rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis


Ages Eligible for Study:   18 Years to 99 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078558

  Show 140 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Veeda Clinical Research
Study Director: Simonne Lens, MD AbbVie sa
  More Information

Additional Information:
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01078558     History of Changes
Other Study ID Numbers: HUM04-28 
Study First Received: March 1, 2010
Last Updated: April 28, 2016
Health Authority: Belgium: Institutional Review Board

Keywords provided by AbbVie:
Multicenter study

Additional relevant MeSH terms:
Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Autoimmune Diseases
Bone Diseases
Bone Diseases, Infectious
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases

ClinicalTrials.gov processed this record on May 26, 2016