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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02150473

Enrollment

Registered

2014-05-29

Start date

2014-10-31

Completion date

2017-09-14

Last updated

2017-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid Arthritis

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.

Interventions

DRUGAdalimumab

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

DRUGPlacebo

Placebo the same amount as adalimumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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 \[ms\]).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026