Belgian Registry of HUMIRA (Adalimumab) in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis - Full Text View

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

This study is currently recruiting participants.

Verified March 2012 by Abbott

First Received on March 1, 2010. Last Updated on April 11, 2012 History of Changes

Sponsor:	Abbott
Collaborator:	Veeda Clinical Research, Brussels
Information provided by (Responsible Party):	Abbott
ClinicalTrials.gov Identifier:	NCT01078558

Purpose

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: HUMIRA (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:

Genetics Home Reference related topics: ankylosing spondylitis psoriatic arthritis

MedlinePlus related topics: Ankylosing Spondylitis Rheumatoid Arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by Abbott:

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:	4500
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: HUMIRA (adalimumab) subcutaneous administration for all patients Other Names: adalimumab 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

Contacts

Contact: Maria Van den Enden	0032 10 47 53 11	maria.vandenenden@abbott.com
Contact: Simonne Lens	0032 10 47 53 11	simonne.lens@abbott.com

Show 139 Study Locations

Sponsors and Collaborators

Abbott

Veeda Clinical Research, Brussels

Investigators

Study Director:

Simonne Lens, MD

Abbott Belgium

More Information

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01078558 History of Changes
Other Study ID Numbers:	HUM04-28
Study First Received:	March 1, 2010
Last Updated:	April 11, 2012
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Abbott:

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 24, 2012