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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 16 December 2017
Main ID:  NCT02150473
Date of registration: 27/02/2014
Prospective Registration: Yes
Primary sponsor: Heinrich-Heine University, Duesseldorf
Public title: The Effect of Adalimumab Plus Methotrexate (MTX) Versus Placebo Plus MTX on Cartilage in (RA) Patients
Scientific title: Delayed Gadolinium-enhanced Magnetic Resonance (MR) Imaging of Cartilage - A Pilot Study to Measure the Effect of Adalimumab Plus MTX Versus Placebo Plus MTX on Cartilage in Early RA Patients
Date of first enrolment: October 2014
Target sample size: 21
Recruitment status: Terminated
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 3
Countries of recruitment
Name:     Benedikt Ostendorf, Prof.Dr.
Affiliation:  Poliklinik für Rheumatologie
Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject has a diagnosis of early RA (ERA) fulfilling the 2010 American college of
rheumatology (ACR) criteria for classification of RA

- Disease duration less than 12 months from symptoms onset.

Exclusion Criteria:

- Subject has previous exposure to any systemic biologic therapy (e.g. abatacept,
tocilizumab) including anti-Tumor necrosis factor (TNF therapy) (e.g., infliximab,
golimumab, certolizumab pegol, etanercept) including adalimumab.

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: Adalimumab
Drug: Placebo
Primary Outcome(s)
Joint space narrowing of the metacarpophalangeal (MCP II) and MCP III joints in the clinically dominant hand measured by variable flip-angle imaging 3 time (3T) MRI [Time Frame: 104 weeks]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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