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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02150473
• Other study ID #: CAR-ERA
• Secondary ID: 2013-004604-19
• Status: Terminated
• Phase: Phase 3
• First received: February 27, 2014
• Last updated: October 17, 2017
• Start date: October 2014
• Est. completion date: September 14, 2017

Study information

• Verified date: October 2017
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: September 14, 2017
• Est. primary completion date: September 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Adalimumab
adalimumab 40 mg every other week in combination with MTX for 24 weeks
• Placebo
Placebo the same amount as adalimumab

Locations

Country	Name	City	State
Germany	Universitätsklinikum Düsseldorf	Düsseldorf	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	Abbott

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]).	104 weeks