The Effect of Adalimumab Plus Methotrexate (MTX) Versus Placebo Plus MTX on Cartilage in (RA) Patients
- Registration Number
- NCT02150473
- Lead Sponsor
- Heinrich-Heine University, Duesseldorf
- Brief Summary
This study aims to compare longitudinally the effect of adalimumab plus methotrexate (MTX) versus MTX monotherapy on cartilage GAG content, reflected by Delayed Gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) index, in patients with early progressive rheumatoid arthritis (RA), who had not previously received any Disease modifying antirheumatic drug (DMARD) or biologic treatment.
- Detailed Description
Patients will be randomly assigned to either adalimumab q2w plus oral MTX qw combination therapy or oral MTX qw monotherapy plus placebo subcutaneous (SC) q2w in a ration 2:1. To maintain blinding, matching placebo SC injections will be dispensed q2w to the MTX monotherapy group. All subjects will receive open-label MTX 15 mg qw as oral tablets. All subjects will take approximately 5 mg weekly dietary supplement of oral folate throughout the study on any day beginning 48 hours after ingestion of their oral study medication. Defined as standard therapy oral folate supplementation will be taken in a single dose 24-48 h after MTX therapy.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 21
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adalimumab Adalimumab receive adalimumab 40 mg eow injections in combination with MTX for 24 weeks Placebo Placebo receive placebo injections in combination with MTX for 24 weeks
- Primary Outcome Measures
Name Time Method 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 104 weeks Joint space narrowing will be measured by variable flip-angle imaging 3T MRI at week 24 and baseline. A possible reduction of the joint space narrowing should be seen by comparing mean intergroup difference of pooled (per patient) dGEMRIC index (T1 \[ms\]).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, NRW, Germany