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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Glostrup University Hospital, Copenhagen.
Recruitment status was  Recruiting
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
  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:


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
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: 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 Rheumatology, Glostrup Hospital Recruiting
Copenhagen, Denmark
Sub-Investigator: Merete L Hetland         
Dep. of Rheumatologym Glostrup Hospital Completed
Copenhagen, Denmark
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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014