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The Efficiency Of The Methotrexate At Patients Affected By Grave Pelade

NCT02037191 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-05-29

No results posted yet for this study

Summary

Alopecia areata (AA) is an auto immune disorder. Treatment of severe types remains difficult with a rate of hair regrowth which is lower than 10%. This RCT will assess the safety and efficacy of methotrexate alone or associated with low doses of prednisone versus placebo in the treatment of severe types of AA.

Conditions

Interventions

DRUG

Methotrexate

Non responder patients in arm A will be re-randomized to receive from month 6 to the end of the study (month 12): methotrexate alone or methotrexate associated with prednisone 0.3 mg/Kg/day

DRUG

Placebo

Non responder patients in arm B will be re-randomized to receive from month 6 to the end of the study (month 12): methotrexate alone or methotrexate associated with prednisone 0.3 mg/Kg/day

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • PASCAL JOLY, PROFESSOR · CHU - Hôpitaux de Rouen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02037191 on ClinicalTrials.gov