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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MOstergaard, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01029613
First received: December 9, 2009
Last updated: August 18, 2015
Last verified: August 2015

December 9, 2009
August 18, 2015
December 2009
July 2013   (Final data collection date for primary outcome measure)
EULAR response criteria [ Time Frame: 16 weeks ]
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 ]
  • Erosions on X-rays and CT [ Time Frame: 52 weeks ]
  • Biomarkers [ Time Frame: 16 and 52 weeks ]
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 ]
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
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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.
 
Completed
40
July 2013
July 2013   (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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01029613
WRAP
Yes
Not Provided
Not Provided
Not Provided
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
August 2015

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