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

December 9, 2009
March 27, 2012
December 2009
September 2012   (final data collection date for primary outcome measure)
EULAR response criteria [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01029613 on ClinicalTrials.gov Archive Site
  • 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 ]
Number of joints with inflammation on MRI, erosions on x-rays and CT, circulating biomarkers of inflammation, cartilage and bone metabolism and conventional clinical parameters of disease activity [ Time Frame: 16 and 52 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Rheumatoid Arthritis
Drug: Adalimumab
sc. inj. Humira 40 mg every other week from week 0 to 52
Rheumatoid arthritis
Intervention: Drug: Adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Mikkel Østergaard, Professor 004538633014 mo@dadlnet.dk
Contact: Susanne J Pedersen 004541431326 susanne_juhl_ped@dadlnet.dk
Denmark
 
NCT01029613
WRAP
Yes
MOstergaard, Glostrup University Hospital, Copenhagen
Glostrup University Hospital, Copenhagen
Not Provided
Principal Investigator: Mikkel Østergaard, Professor Dep. of Rheumatology, Glostrup Hospital
Study Chair: Susanne J Pedersen, MD Dep. of Rheumatology, Glostrup Hospital
Glostrup University Hospital, Copenhagen
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP