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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029613
• Other study ID #: WRAP
• Status: Completed
• Phase: N/A
• First received: December 9, 2009
• Last updated: August 18, 2015
• Start date: December 2009
• Est. completion date: July 2013

Study information

• Verified date: August 2015
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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-a inhibitor treatment by the treating physician

• No contraindications for TNF-a 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-a 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Adalimumab
sc. inj. Humira 40 mg every other week from week 0 to 52

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EULAR response criteria		16 weeks	No
Secondary	Number of joints with inflammation on MRI		16 and 52 weeks	No
Secondary	Erosions on X-rays and CT		52 weeks	No
Secondary	Biomarkers		16 and 52 weeks	No