MedTrace Logo

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

NCT02150473 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-10-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Adalimumab

adalimumab 40 mg every other week in combination with MTX for 24 weeks

DRUG

Placebo

Placebo the same amount as adalimumab

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Benedikt Ostendorf, Prof.Dr. · Poliklinik für Rheumatologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-09-14
Completion
2017-09-14

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02150473 on ClinicalTrials.gov