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

• Register: ClinicalTrials.gov
• Last refreshed on: 31 August 2015
• Main ID: NCT01029613
• Date of registration: 09/12/2009
• Prospective Registration: No
• Primary sponsor: Glostrup University Hospital, Copenhagen
• Public title: Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers
• Scientific 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
• Date of first enrolment: December 2009
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01029613
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Mikkel Østergaard, Professor
• Affiliation: Dep. of Rheumatology, Glostrup Hospital

• Name: Susanne J Pedersen, MD
• Affiliation: Dep. of Rheumatology, Glostrup Hospital

Key inclusion & exclusion 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-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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Adalimumab

Primary Outcome(s)

EULAR response criteria [Time Frame: 16 weeks]

Secondary Outcome(s)

Biomarkers [Time Frame: 16 and 52 weeks]

Erosions on X-rays and CT [Time Frame: 52 weeks]

Number of joints with inflammation on MRI [Time Frame: 16 and 52 weeks]

Secondary ID(s)

WRAP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors