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The Effect of Adalimumab Plus Methotrexate (MTX) Versus Placebo Plus MTX on Cartilage in (RA) Patients

Information source: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Adalimumab (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Heinrich-Heine University, Duesseldorf

Official(s) and/or principal investigator(s):
Benedikt Ostendorf, Prof.Dr., Principal Investigator, Affiliation: Poliklinik für Rheumatologie

Overall contact:
Benedikt Ostendorf, Prof.Dr., Phone: 4902118117817, Email: ostendorf@med.uni-duesseldorf.de


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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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

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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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.

Locations and Contacts

Benedikt Ostendorf, Prof.Dr., Phone: 4902118117817, Email: ostendorf@med.uni-duesseldorf.de

Universitätsklinikum Düsseldorf, Düsseldorf, NRW 40225, Germany; Recruiting
Benedikt Ostendorf, Prof.Dr., Phone: 4921181117817, Email: ostendorf@med.uni-duesseldorf.de
Benedikt Ostendorf, Prof.Dr., Principal Investigator
Additional Information

Starting date: October 2014
Last updated: May 7, 2015

Page last updated: August 23, 2015

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