The Efficiency Of The Methotrexate At Patients Affected By Grave Pelade

NCT02037191 | Completed Phase 3

• 1 other identifier: 2011/121/HP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

ALOPECIA AREATA

Keywords

ALOPECIA AREATA; TREATMENT METHOTREXATE

Outcome Measures

Primary Outcomes (1)

• OUTCOME MESURE

  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

  MONTH12

Secondary Outcomes (1)

• SECONDARY OUTCOME MEASURE

  MONTH 6 TO 12

Study Arms (2)

ARM A : METHOTREXATE

PLACEBO COMPARATOR

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

Drug: Methotrexate

ARM B : PLACEBO

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Methotrexate DRUG

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

Also known as: Arm A: methotrexate 20 to 25 mg / week for 6 months.

ARM A : METHOTREXATE

Placebo DRUG

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

ARM B : PLACEBO

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- age 18 to 70 years old
• \- informed consent,
• \- 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

You may not qualify if:

• Pregnant or breast feeding women
• VIH + patients
• active hepatitis B or C
• treatment with immunosuppressant (ciclosporine, mycophénolate mofetil
• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (2)

Head Dermatology Department

Rouen, Haute Normandie, 76031, France

Location

CHU de Rouen - Hôpitaux de Rouen

Rouen, Seine Maritime, 76031, France

Location

Related Publications (1)

• Joly P, Lafon A, Houivet E, Donnadieu N, Richard MA, Dupuy A, Delaporte E, Bernard P, Machet L, Tosti A, Del Marmol V, Grimalt R, de Viragh PA, Benichou J, Chosidow O, Assouly P, Reygagne P. Efficacy of Methotrexate Alone vs Methotrexate Plus Low-Dose Prednisone in Patients With Alopecia Areata Totalis or Universalis: A 2-Step Double-Blind Randomized Clinical Trial. JAMA Dermatol. 2023 Apr 1;159(4):403-410. doi: 10.1001/jamadermatol.2022.6687.

  PMID: 36884234 DERIVED

MeSH Terms

Conditions

Alopecia Areata

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• PASCAL JOLY, PROFESSOR

  CHU - Hôpitaux de Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 29, 2018

Record last verified: 2018-05

Locations

FR (2)