This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01078558
First received: March 1, 2010
Last updated: July 10, 2017
Last verified: July 2017
  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
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 ( AbbVie (prior sponsor, 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 ]
  • Safety parameters/ SAE reporting [ Time Frame: 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months ]

Estimated Enrollment: 5914
Study Start Date: May 13, 2004
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with rheumatic disease
Patients suffering from rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis

  Eligibility

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
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
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
Investigators
Study Director: Simonne Lens, MD AbbVie sa
  More Information

Additional Information:
Responsible Party: 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: July 10, 2017

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

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

ClinicalTrials.gov processed this record on July 19, 2017