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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01078558
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : January 17, 2018
Veeda Clinical Research
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
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).

Condition or disease
Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis

Study Type : Observational
Actual Enrollment : 5832 participants
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)
Study Start Date : May 13, 2004
Primary Completion Date : January 11, 2018
Study Completion Date : January 11, 2018

Patients with rheumatic disease
Patients suffering from rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis

Primary Outcome Measures :
  1. 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 ]
  2. Safety parameters/ SAE reporting [ Time Frame: 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078558

  Show 118 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Veeda Clinical Research
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01078558     History of Changes
Other Study ID Numbers: HUM04-28
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Multicenter study

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