Serum Concentration of Adalimumab as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)
NCT ID: NCT01382160
Last Updated: 2013-10-07
Study Results
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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COMPLETED
PHASE4
69 participants
INTERVENTIONAL
2011-01-31
2013-07-31
Brief Summary
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However, almost one third of patients have no response and approximately 15% develop antibodies towards adalimumab (ATA) after a 6 month course of treatment. There is a relationship between adalimumab concentration and clinical response obtained after 6 month of treatment. Furthermore adalimumab concentration measured 3 months after initiation seems to predict the clinical response at 6 months.
There is an important inter individual pharmacokinetic variability of adalimumab. Side effects may occur at the recommended dose and more than 3 months of treatment are generally required to estimate the clinical response.
A therapeutic drug monitoring could help clinicians to early adjust the dose to optimize the response and to avoid dose related side effects. To date there is no definite adalimumab target concentration predictive of the clinical response to allow such a pharmacologic monitoring.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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adalimumab
40 mg every two weeks, by subcutaneous way
adalimumab
40 mg every two weeks, by subcutaneous way
Interventions
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adalimumab
40 mg every two weeks, by subcutaneous way
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment with Adalimumab has been chosen by the physician / patient
* Treatment given in accordance to the SPC
* Stable Disease modifying anti rheumatic drugs (DMARDs) and glucocorticoids 4 weeks before enrollment and during the study period.
* Signed consent
Exclusion Criteria
* Past history of malignancy, AIDS
* Pregnancy
* Change in DMARDS or glucocorticoid dose 4 weeks before entering the study
* Active or latent tuberculosis, other active infections
* Surgery scheduled during the study period
18 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Denis MULLEMAN, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHRU de Tours
Locations
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CHRU de Brest
Brest, , France
CHR du Mans
Le Mans, , France
CHRU de Nantes
Nantes, , France
CHR d'Orléans
Orléans, , France
CHRU de Poitiers
Poitiers, , France
CHRU de Rennes
Rennes, , France
CHRU de Tours
Tours, , France
Countries
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Other Identifiers
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2010-021449-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A100898-30
Identifier Type: OTHER
Identifier Source: secondary_id
2010-R24
Identifier Type: OTHER
Identifier Source: secondary_id
PHRI10-DM/AFORA
Identifier Type: -
Identifier Source: org_study_id