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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01029613
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Rheumatoid Arthritis Drug: Adalimumab

Study Design

Study Type : Observational
Actual Enrollment : 40 participants
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
Study Start Date : December 2009
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

Group/Cohort Intervention/treatment
Rheumatoid arthritis Drug: Adalimumab
sc. inj. Humira 40 mg every other week from week 0 to 52


Outcome Measures

Primary Outcome Measures :
  1. EULAR response criteria [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Number of joints with inflammation on MRI [ Time Frame: 16 and 52 weeks ]
  2. Erosions on X-rays and CT [ Time Frame: 52 weeks ]
  3. Biomarkers [ Time Frame: 16 and 52 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029613


Locations
Denmark
Dep. of medicine, Herlev Hospital
Copenhagen, Denmark
Dep. of Radiology, Herlev Hospital
Copenhagen, Denmark
Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals
Copenhagen, Denmark
Dep. of Rheumatology, Gentofte Hospital
Copenhagen, Denmark
Dep. of Rheumatology, Glostrup Hospital
Copenhagen, Denmark
Dep. of Rheumatologym Glostrup Hospital
Copenhagen, Denmark
Dep. of Rheumatology, Helsingør Hospital
Hørsholm, Denmark
Dep. of Rheumatology, Køge Hospital
Køge, Denmark
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

Responsible Party: MOstergaard, Professor, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01029613     History of Changes
Other Study ID Numbers: WRAP
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

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