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The Efficiency Of The Methotrexate At Patients Affected By Grave Pelade (MP3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02037191
Recruitment Status : Completed
First Posted : January 15, 2014
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Tracking Information
First Submitted Date  ICMJE January 13, 2014
First Posted Date  ICMJE January 15, 2014
Last Update Posted Date May 28, 2018
Actual Study Start Date  ICMJE February 2014
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2014)
OUTCOME MESURE [ Time Frame: MONTH12 ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02037191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2014)
SECONDARY OUTCOME MEASURE [ Time Frame: MONTH 6 TO 12 ]
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficiency Of The Methotrexate At Patients Affected By Grave Pelade
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ALOPECIA AREATA
Intervention  ICMJE
  • 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

    Other Name: Arm A: methotrexate 20 to 25 mg / week for 6 months.
  • 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

Study Arms  ICMJE
  • Placebo Comparator: ARM A : METHOTREXATE

    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
    Intervention: Drug: Methotrexate
  • Placebo Comparator: ARM B : PLACEBO

    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
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2014)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02037191
Other Study ID Numbers  ICMJE 2011/121/HP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Rouen
Study Sponsor  ICMJE University Hospital, Rouen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: PASCAL JOLY, PROFESSOR CHU - Hôpitaux de Rouen
PRS Account University Hospital, Rouen
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP