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Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers

This study is currently recruiting participants.
Verified March 2012 by Glostrup University Hospital, Copenhagen
Sponsor:
Information provided by (Responsible Party):
MOstergaard, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01029613
First received: December 9, 2009
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  Purpose

Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers. Furthermore to compare ultrasound examination with wholebody MRI etc.


Condition Intervention
Rheumatoid Arthritis
 Drug: Adalimumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adalimumab in Rheumatoid Arthritis. An Investigation of Changes in Disease Activity and Course of Joint Destruction by Use of 3 Tesla Whole-Body MRI, Dedicated 3 Tesla MRI and CT of the Hand, and Soluble Biomarkers

Resource links provided by NLM:

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

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • EULAR response criteria [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of joints with inflammation on MRI [ Time Frame: 16 and 52 weeks ] [ Designated as safety issue: No ]
  • Erosions on X-rays and CT [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Biomarkers [ Time Frame: 16 and 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rheumatoid arthritis Drug: Adalimumab
sc. inj. Humira 40 mg every other week from week 0 to 52

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with rheumatoid arthritis according to the ACR criteria (1987) with high disease activity starting TNF-alpha inhibitor

Criteria

Inclusion Criteria:

  • Age > 18 years old and < 85 years old
  • RA in accordance with American College of Rheumatology 1987 criteria
  • Moderate or highly active RA defined as DAS28 > 3,2 (CRP based)
  • Clinical indication for TNF-α inhibitor treatment by the treating physician
  • No contraindications for TNF-α inhibitor treatment
  • No contraindications for MRI
  • Serum creatinine in normal range
  • Sufficient contraception for fertile women
  • Capable of giving informed consent
  • Capable of complying with the examination program of the protocol

Exclusion Criteria:

  • Other DMARDs than MTX from less than 4 weeks before inclusion and throughout the study period
  • Cyclophosphamide, Chlorambucil or other alkylating agents from less than 4 weeks before inclusion and throughout the study period
  • Intramuscular or intravenous injection of glucocorticoid from less than 4 weeks before inclusion and throughout the study period
  • Pregnancy wish, pregnancy or breast-feeding
  • Contraindications for TNF-α inhibitor treatment
  • Contraindications for MRI
  • Known recent drug or alcohol abuse
  • Failure to provide written consent
  • Incapable of complying with the examination program for physical or mental reasons
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029613

Contacts
Contact: Mikkel Østergaard, Professor 004538633014 mo@dadlnet.dk
Contact: Susanne J Pedersen 004541431326 susanne_juhl_ped@dadlnet.dk

Locations
Denmark
Dep. of medicine, Herlev Hospital Recruiting
Copenhagen, Denmark
Sub-Investigator: Julia S Johansen            
Dep. of Radiology, Herlev Hospital Recruiting
Copenhagen, Denmark
Sub-Investigator: Jakob Møller            
Sub-Investigator: Maria Hasselquist            
Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals Recruiting
Copenhagen, Denmark
Sub-Investigator: Gina Kollerup            
Dep. of Rheumatology, Gentofte Hospital Recruiting
Copenhagen, Denmark
Sub-Investigator: Ole R Madsen            
Sub-Investigator: Michael S Hansen            
Dep. of Rheumatologym Glostrup Hospital Completed
Copenhagen, Denmark
Dep. of Rheumatology, Glostrup Hospital Recruiting
Copenhagen, Denmark
Sub-Investigator: Merete L Hetland            
Dep. of Rheumatology, Helsingør Hospital Recruiting
Hørsholm, Denmark
Sub-Investigator: Dorte V Jensen            
Dep. of Rheumatology, Køge Hospital Recruiting
Køge, Denmark
Sub-Investigator: Michael Stoltenberg            
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Mikkel Østergaard, Professor Dep. of Rheumatology, Glostrup Hospital
Study Chair: Susanne J Pedersen, MD Dep. of Rheumatology, Glostrup Hospital
  More Information

No publications provided

Responsible Party: MOstergaard, Professor, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01029613     History of Changes
Other Study ID Numbers: WRAP
Study First Received: December 9, 2009
Last Updated: March 27, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 17, 2013