The Efficiency Of The Methotrexate At Patients Affected By Grave Pelade
Condition: ALOPECIA AREATA
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

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
    

Intervention name(s): Methotrexate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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
Other intervention name(s): Arm A: methotrexate 20 to 25 mg / week for 6 months.
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ALOPECIA AREATA; TREATMENT METHOTREXATE