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

NCT ID: NCT02150473

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-09-14

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Keywords

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rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Adalimumab

receive adalimumab 40 mg eow injections in combination with MTX for 24 weeks

Group Type EXPERIMENTAL

Adalimumab

Intervention Type DRUG

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

Placebo

receive placebo injections in combination with MTX for 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo the same amount as adalimumab

Interventions

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Adalimumab

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

Intervention Type DRUG

Placebo

Placebo the same amount as adalimumab

Intervention Type DRUG

Other Intervention Names

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Humira

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benedikt Ostendorf, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Poliklinik für Rheumatologie

Locations

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Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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2013-004604-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAR-ERA

Identifier Type: -

Identifier Source: org_study_id