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Predictors of the Response to Adalimumab in Rheumatoid Arthritis

Predictors of the Response to Adalimumab in Rheumatoid Arthritis

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00234234
Enrollment
200
Registered
2005-10-06
Start date
2006-01-31
Completion date
2008-12-31
Last updated
2012-02-09

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

Conditions

Rheumatoid Arthritis

Keywords

Biologics

Brief summary

Rheumatoid arthritis (RA) is the most common inflammatory rheumatic disease which is characterized by joint inflammation (clinical involvement), by osteo-cartilaginous lesions (structural damage) and generally by bone involvement. All those features lead to great disability. Because it represents a major problem of the public health care system, RA has been selected as one of the main objectives of the government for the next five years. RA patients who do not respond to DMARDs require a treatment by TNF-a blocking agents. However, no information is available to predict the clinical, structural and bone responses to those new drugs that can be responsible of severe side-effects. Moreover, they are particularly expensive since their yearly cost is estimated between 75000 and 112500 k euros for the G4 region. The purpose of the present research project is to determine potential predictive factors of the response to a new TNF-a blocker ie adalimumab. To address this question, several investigations will be performed including measurement of different blood markers, particularly bone markers, well-defined autoantibodies and new autoantibody populations identified by proteomic analysis, large-scale analysis of gene expression with cDNA arrays from blood mononuclear cells, and use of different imaging tools. The criteria of judgement will be the clinical, structural and bone responses to those new agents. This study requires the recruitment of about 100 patients receiving adalimumab for a 1-year period. At the end of the study, we hope to identify predictive factors of the response to adalimumab, which will lead to a better management of this TNF-a blocker. Indeed, they will be prescribed only for the patients who are likely to respond to those drugs. Thus, this study should allow to elaborate theranostic algorithms. Such an approach will have great benefits for the patients: more rapid efficacy, less severe side-reactions and lower costs.

Interventions

DRUGAdalimumab

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ACR classification criteria of RA * DAS 28 \> 5.1 * inadequately controlled by at least one DMARD * biologics naïve

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frame
Clinical response
Structural response : X-rays
Bone response : osteodensitometry

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026