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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Veeda Clinical Research, Brussels
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01078558
First received: March 1, 2010
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
 Biological: adalimumab

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, Psoriatic Arthritis or Ankylosing Spondylitis Who Are Treated With HUMIRA (Adalimumab)

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

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)
Groups/Cohorts Assigned Interventions
Patients with rheumatic disease
Patients suffering from rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis
 Biological: adalimumab
subcutaneous administration for all patients
Other Name: HUMIRA

  Eligibility

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

Rheumatologists

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).
  Contacts and Locations
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, Brussels
Investigators
Study Director: Simonne Lens, MD AbbVie SA
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

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 11, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by AbbVie:
Multicenter study

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
 Skin Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Ankylosis
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013