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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01029613

Enrollment

Registered

2009-12-10

Start date

2009-12-31

Completion date

2013-07-31

Last updated

2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGAdalimumab

sc. inj. Humira 40 mg every other week from week 0 to 52

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
EULAR response criteria	16 weeks

Secondary

Measure	Time frame
Number of joints with inflammation on MRI	16 and 52 weeks
Erosions on X-rays and CT	52 weeks
Biomarkers	16 and 52 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026