The Efficiency Of The Methotrexate At Patients Affected By Grave Pelade

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Brief Title

The Efficiency Of The Methotrexate At Patients Affected By Grave Pelade

Official Title

RANDOMIZED DOUBLE-BLIND STUDY MULTICENTRIQUE TESTING THE EFFICIENCY OF the METHOTREXATE AT PATIENTS AFFECTED BY GRAVE PELADE (METHOTREXATE VERSUS PLACEBO WITH SECONDARY TREATMENT BY METHOTREXATE and PREDNISONE)

Brief 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.
    

Detailed Description

      Background: Alopecia areata (AA) is an auto immune disorder. Chronic and severe types of AA
      have a major impact on patients' quality of life. Treatment of severe types of AA include
      phototherapy, pulse IV corticosteroids, topical immunotherapy. These treatments are poorly
      effective in severe types of AA, since the rate of hair regrowth remains lower than 10%.
      Methotrexate is an immunosuppressant which is used in many autoimmune skin disorders.

      Aim: To assess the safety and efficacy of methotrexate versus placebo in the treatment of
      severe types of AA.

      Design: Patients will be randomly assigned to receive methotrexate 20 to 25 mg / week for 6
      months. Patients who will experience at least a 25% hair regrowth after 5 months will
      continue methotrexate or placebo from month 6 to the end of the study (month 12). Non
      responder patients will be re randomized to receive either methotrexate alone or associated
      with prednisone 0.3 mg/Kg/day from month 6 to the end of the study (month 12).

      Study Design Primary outcome Rate of complete or almost complete hair regrowth at the month
      12 evaluation in patients treated with methotrexate or placebo who have not been re
      randomized after the month 5 evaluation and have staid in their initial group of
      randomization Secondary outcomes

        1. Rate of Global Regrowth Assesment (GRA) at month 6 and 12 .

        2. Delay of hair regrowth

        3. Rate of relapse

        4. Quality of life

        5. Safety

      Arm description Arm A: methotrexate 20 to 25 mg / week for 6 months. Arm B placebo Patients
      who will experience at least a 25% hair regrowth after the month 5 evaluation will continue
      methotrexate or placebo from month 6 to the end of the study (month 12).

      Non responder patients in both arms A and 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 10 A study population Adult
           patients with severe types of AA evolving without hair regrowth for at least 6 months
           despite previous treatments with impaired quality of life

      Eligibility criteria Inclusion criteria

        1. age 18 TO 70 years old

        2. informed consent,

        3. severe type of AA defined as : 3.1 - AA totalis universalis 3.2 - evolving for more than
           6 months despite previous treatments including photothérapy (PUVA oru UVB), applications
           of super potent topical corticosteroid ( clobetasol propionate), applications of
           minoxidil 5%, or IV pulse corticosteroids 3.3 - DLQI score inferior or equal to 10

      Non inclusion criteria

        -  Pregnant or breast feeding women

        -  VIH + patients

        -  active hepatitis B or C

        -  treatment with immunosuppressant (ciclosporine, mycophénolate mofetil, cyclophosphamide,
           azathioprine, méthotrexate) within 2 months before inclusion

        -  severe cardiac arythma or severe cardiac insufficiency or severe coronary disease

        -  liver disorder

        -  alcool consumption

        -  renal failure

        -  Severe diabetes mellitus

        -  past history of severe infection

        -  past history of néoplasiae ( excluding BCC),

        -  Karnofsky index <à 50 %

        -  severe lung disorder

        -  mental impairment

        -  symptomatic osteoporosis

        -  blood cytopénia (hémoglobine < 10 g/l ; leucocytes< 3000/mm3, platelets< 100 000/mm3)

        -  albuminémia < 25 g/l
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

OUTCOME MESURE

Secondary Outcome

 SECONDARY OUTCOME MEASURE

Condition

ALOPECIA AREATA

Intervention

Methotrexate

Study Arms / Comparison Groups

 ARM A : METHOTREXATE
Description:  Arm A: methotrexate 20 to 25 mg / week for 6 months. Patients who will experience at least a 25% hair regrowth after the month 5 evaluation will continue methotrexate or placebo from month 6 to the end of the study (month 12).
Non responder patients in both arms A and 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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

90

Start Date

February 2014

Completion Date

December 2017

Primary Completion Date

December 2017

Eligibility Criteria

        Inclusion Criteria:

          1. - age 18 to 70 years old

          2. - informed consent,

          3. - severe type of AA defined as : 3.1 - AA totalis universalis 3.2 - evolving for more
             than 6 months despite previous treatments including photothérapy (PUVA oru UVB),
             applications of super potent topical corticosteroid ( clobetasol propionate),
             applications of minoxidil 5%, or IV pulse corticosteroids 3.3 - DLQI score superior or
             equal to 10

        Exclusion Criteria:

          -  Pregnant or breast feeding women

          -  VIH + patients

          -  active hepatitis B or C

          -  treatment with immunosuppressant (ciclosporine, mycophénolate mofetil

             , cyclophosphamide, azathioprine, méthotrexate) within 2 months before inclusion

          -  severe cardiac arythma or severe cardiac insufficiency or severe coronary disease

          -  liver disorder

          -  alcool consumption

          -  renal failure

          -  Severe diabetes mellitus

          -  past history of severe infection

          -  past history of néoplasiae ( excluding BCC),

          -  Karnofsky index <à 50 %

          -  severe lung disorder

          -  mental impairment

          -  symptomatic osteoporosis

          -  blood cytopénia (hémoglobine < 10 g/l ; leucocytes< 3000/mm3, platelets< 100 000/mm3)

          -  albuminémia < 25 g/l
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

PASCAL JOLY, PROFESSOR, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02037191

Organization ID

2011/121/HP


Responsible Party

Sponsor

Study Sponsor

University Hospital, Rouen


Study Sponsor

PASCAL JOLY, PROFESSOR, Principal Investigator, CHU - Hôpitaux de Rouen


Verification Date

May 2018