- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03775460
Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum (MaPs)
March 10, 2023 updated by: London School of Hygiene and Tropical Medicine
Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum (MaPS in ENL
Erythema Nodosum Leprosum (ENL) is a painful, debilitating complication of leprosy.
Patients often require high doses of corticosteroids for prolonged periods.
Thalidomide is expensive and not available in most countries.
The use of corticosteroids for long periods is associated with adverse effects and mortality.
It is a priority to identify alternative agents to treat ENL.
Methotrexate (MTX) is a cheap, widely used medication which has been reported to be effective in ENL resistant to steroids and thalidomide.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a double blind randomized controlled trial (RCT) to test the efficacy of MTX for managing ENL.
Patients diagnosed with moderate or severe ENL at ENLIST Group centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal will be randomly allocated to receive a 15 or 20 mg of oral MTX each week for 48 weeks and prednisolone 40 mg per day reducing to zero over 20 weeks.
The control group will receive an identical prednisolone scheme.
The participants will be stratified into two groups, those with acute ENL, those with chronic/recurrent ENL.
The interventions for both populations are the same, although analysed separately.
Adverse effects (AE) will be closely monitored clinically and using laboratory tests.
Participants will receive folic acid, 5mg daily for 52 weeks except on the day of MTX to prevent AEs, and nausea will be managed with ondansetron.
Study Type
Interventional
Enrollment (Anticipated)
550
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Barbara de Barros, M.D
- Phone Number: +44(0)2079272316
- Email: barbara.de-barros@lshtm.ac.uk
Study Locations
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Dhaka, Bangladesh
- Not yet recruiting
- TMLI Bangladesh/ DBLM hospital
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Contact:
- Benjamin Jewel Rozario
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Rio De Janeiro, Brazil
- Not yet recruiting
- FIOCRUZ
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Contact:
- Jose' Nery
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Addis Ababa, Ethiopia
- Not yet recruiting
- ALERT
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Contact:
- Saba Lambert
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Delhi, India
- Recruiting
- The Leprosy Mission Trust
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Contact:
- Joydeepa Darlong
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Mumbai, India
- Recruiting
- Bombay Leprosy Project
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Contact:
- Vivek Pai
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Surabaya, Indonesia
- Not yet recruiting
- Soetomo Hospital
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Contact:
- Medhi Alinda
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Kathmandu, Nepal
- Not yet recruiting
- Anandaban Hospital
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Contact:
- Deanna Hagge
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:: ALL OF THE FOLLOWING SIX CRITERIA MUST BE MET IN ORDER FOR AN INDIVIDUAL TO BE ELIGIBLE (ONLY ONE OF 6A TO 6D NEED BE MET):
- Individuals who diagnosed with leprosy complicated by ENL
- Individuals with ENL aged 18-60 years old
- Individuals with ENL deteriorating symptoms
- Individuals with 10 or more tender, papular or nodular ENL skin lesions
- Individuals with an EESS score of at least 9
Individuals with ENL on:
- No current anti- ENL treatment
- Prednisolone up to 30mg per day (if ACUTE) or Prednisolone 10-30mg (inclusive) per day (if RECURRENT/ CHRONIC) or equivalent alternative corticosteroid dose OR
- Thalidomide or other non-steroidal anti-ENL medication OR
- A combination of prednisolone (up to 30mg) and another non-steroidal anti-ENL medication (thalidomide, clofazimine, azathioprine, pentoxifylline, ciclosporin, minocycline)
Exclusion criteria:
- Individuals who were first diagnosed with ENL more than 4 years prior to enrolment
- Individuals less than 18 years old or older than 60 years
- Individuals weighing less than 35kg
- Individuals with 9 or fewer tender, popular or nodular ENL skin lesions
- Individuals with an EESS score of 8 or less
- Women of child bearing capacity who decline to use two forms of adequate contraception and men who decline to use two forms of adequate contraception
- Pregnant or breastfeeding women
- Individuals with recurrent or chronic ENL who deteriorate on a dose of prednisolone less than 10 mg or more than 30 mg
- Individuals who have taken methotrexate by any route for the last 12 weeks
- Individuals with a hypersensitivity to methotrexate or a recognised contraindication ( please see Methotrexate information sheet)
- Individuals currently diagnosed with Type 1 reaction or Lucio's phenomenon
- Individuals with the severe abnormalities in screening investigations
- Positive serology for HIV, Hepatitis B or C
- Evidence of tuberculosis or pulmonary fibrosis
- A history of chronic liver disease or excessive alcohol or illicit substance consumption
- Individuals with severe inter-current infections, uncontrolled diabetes, active peptic ulcer disease, untreated malignancy
- Individuals unable to attend regularly for assessment or monitoring
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: control
Participants will receive placebo+ prednisolone.
Participants will start receiving 4 dummy tablets per week, than participants weighing less than 60 kg will receive 6 dummy tablets from week 8.
The placebo will be prescribe weekly.
Participants weighing 60 kg or more will receive 8 dummy tablets from week 8. Participants will receive dummy tablets for 52 weeks.
Along with prednisolone.
The start dose of prednisolone will be 40 mg per day decreasing dosage for 20 weeks.
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Participants in the control arm will receive placebo along side prednisolone
Participants in both arm will receive prednisolone, which will be the same dosage: 40 mg (initial dose) decreasing dosage for 20 weeks
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Experimental: intervention
Participants will receive Methotrexate(MTX)+prednisolone.
All participants in intervention arm will receive an initial dose of MTX 10 mg.
The MTX will be increased to 15 mg the following week.
Participants weighing less than 60 kg will continue to receive 15 mg of MTX weekly thereafter.
Individuals weighing 60 kg or more will receive MTX 20 mg from week 8.
At week 48 the MTX will be reduced to 10 mg for two weeks followed by 5 mg for two weeks and then stopped.
In total participants will receive 52 weeks of MTX along side prednisolone, which will be the same as the control arm.
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Participants in both arm will receive prednisolone, which will be the same dosage: 40 mg (initial dose) decreasing dosage for 20 weeks
Participants in the intervention group will receive methotrexate along side prednisolone
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of individuals free from Erythema Nodosum Leprosum (ENL) flares in 24 weeks
Time Frame: During the first 24 weeks
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Proportion of individuals who have not required additional prednisolone during the first 24 weeks.
The aim is to evaluate if individuals in the methotrexate regimen will need less prednisolone than the control arm.
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During the first 24 weeks
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Proportion of individuals free from ENL flares in 48 weeks
Time Frame: During first 48 weeks
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Proportion of individuals who have not required additional prednisolone during the first 48 weeks.
To evaluate if methotrexate will be more efficient to control ENL than only prednisolone
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During first 48 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in ENLIST ENL severity scale score (EESS)
Time Frame: 60 weeks
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ENLIST group (Erythema Nodosum Leprosum International STudy) developed and validated a severity scale for ENL, which consist 10 symptoms and signs of ENL and range from 0 to 30 points.
Mild ENL is categorised as an score of 8 or less.
We will measure the change in ENLIST ENL Severity Scale score from baseline to the first flare of ENL requiring additional prednisolone
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60 weeks
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Quality of life changes: 36- Item Short Form (SF-36) questionnaire
Time Frame: at 24 and 48 weeks
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Change in patient reported health-related quality of life at 24 and 48 weeks from baseline.
This will be measured by 36- Item Short Form (SF-36) questionnaire developed by RAND, validated worldwide.
The SF-36 consists of 8 scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale.
The lower the score the more disability.
If the score is 0 is equivalent to maximum disability.
The 8 sections are vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, emotional role functioning, social role functioning and mental health.
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at 24 and 48 weeks
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Quality of life changes regarding skin condition: Dermatology life quality Index (DLQI)
Time Frame: at 24 and 48 weeks
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Change in patient reported health-related quality of life at 24 and 48 weeks, specific to skin condition, such as ENL.
It will be used the Dermatology life quality Index (DLQI),which is a questionnaire of 10 questions to specific evaluate quality of life in dermatologic conditions.The score can range from 0 to 30, meaning 0 no effect at all on patient's life to 30 extremely large effect on patient's life.
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at 24 and 48 weeks
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Proportion of individuals free from ENL flares at 60 weeks
Time Frame: 60 weeks
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Proportion of individuals who do not require prednisolone at 60 weeks
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60 weeks
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ENL flares per individual up to 60 weeks
Time Frame: 60 weeks
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Number of flares of ENL per individual requiring additional prednisolone up to 60 weeks
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60 weeks
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Severity of ENL flares
Time Frame: 60 weeks
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As stated on outcome 3, the severity of ENL will be measured by ENLIST ENL severity scale.
The scale is composed by 10 symptoms and signs of ENL and range from 0 to 30 points.
Mild ENL is categorised as an score of 8 or less.
We will measure the maximum severity of flares of ENL requiring additional prednisolone up to 60 weeks
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60 weeks
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Time to the first flare of ENL
Time Frame: 60 weeks
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How long it takes to a participant who has an ENL flare to present with first episode of flare after enrolment
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60 weeks
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Adverse effects
Time Frame: 60 weeks
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Proportion of individuals with treatment related adverse effects
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60 weeks
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Quality of life at 60 weeks: SF-36 questionnaire
Time Frame: 60 weeks
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As described on outcome 4. We will use SF-36 questionnaire to measure quality of life.
Change in patient reported health-related quality of life at 60 weeks from baseline
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60 weeks
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Quality of life at 60 weeks regarding skin condition: Dermatology Life Quality Index (DLQI) questionnaires
Time Frame: 60 weeks
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As described on outcome 5. We will use DLQI questionnaires to measure quality of life.
Change in patient reported health-related quality of life at 60 weeks from baseline, specific to skin conditions such as ENL.
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60 weeks
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Individuals free from ENL flares in 60 weeks
Time Frame: 60 weeks
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Proportion of individuals who have not required additional prednisolone in the 60 weeks of the trial
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60 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stephen Walker, MD, PhD, London School of Hygiene and Tropical Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Walker SL, Sales AM, Butlin CR, Shah M, Maghanoy A, Lambert SM, Darlong J, Rozario BJ, Pai VV, Balagon M, Doni SN, Hagge DA, Nery JAC, Neupane KD, Baral S, Sangma BA, Alembo DT, Yetaye AM, Hassan BA, Shelemo MB, Nicholls PG, Lockwood DNJ; Erythema Nodosum Leprosum International STudy Group. A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale. PLoS Negl Trop Dis. 2017 Jul 3;11(7):e0005716. doi: 10.1371/journal.pntd.0005716. eCollection 2017 Jul.
- Lambert SM, Nigusse SD, Alembo DT, Walker SL, Nicholls PG, Idriss MH, Yamuah LK, Lockwood DN. Comparison of Efficacy and Safety of Ciclosporin to Prednisolone in the Treatment of Erythema Nodosum Leprosum: Two Randomised, Double Blind, Controlled Pilot Studies in Ethiopia. PLoS Negl Trop Dis. 2016 Feb 26;10(2):e0004149. doi: 10.1371/journal.pntd.0004149. eCollection 2016 Feb.
- Pocaterra L, Jain S, Reddy R, Muzaffarullah S, Torres O, Suneetha S, Lockwood DN. Clinical course of erythema nodosum leprosum: an 11-year cohort study in Hyderabad, India. Am J Trop Med Hyg. 2006 May;74(5):868-79.
- Kumar B, Dogra S, Kaur I. Epidemiological characteristics of leprosy reactions: 15 years experience from north India. Int J Lepr Other Mycobact Dis. 2004 Jun;72(2):125-33. doi: 10.1489/1544-581X(2004)0722.0.CO;2.
- Chandler DJ, Hansen KS, Mahato B, Darlong J, John A, Lockwood DN. Household costs of leprosy reactions (ENL) in rural India. PLoS Negl Trop Dis. 2015 Jan 15;9(1):e0003431. doi: 10.1371/journal.pntd.0003431. eCollection 2015 Jan.
- Walker SL, Lebas E, Doni SN, Lockwood DN, Lambert SM. The mortality associated with erythema nodosum leprosum in Ethiopia: a retrospective hospital-based study. PLoS Negl Trop Dis. 2014 Mar 13;8(3):e2690. doi: 10.1371/journal.pntd.0002690. eCollection 2014 Mar.
- Walker SL, Waters MF, Lockwood DN. The role of thalidomide in the management of erythema nodosum leprosum. Lepr Rev. 2007 Sep;78(3):197-215.
- Wemambu SN, Turk JL, Waters MF, Rees RJ. Erythema nodosum leprosum: a clinical manifestation of the arthus phenomenon. Lancet. 1969 Nov 1;2(7627):933-5. doi: 10.1016/s0140-6736(69)90592-3. No abstract available.
- Moraes MO, Sarno EN, Almeida AS, Saraiva BC, Nery JA, Martins RC, Sampaio EP. Cytokine mRNA expression in leprosy: a possible role for interferon-gamma and interleukin-12 in reactions (RR and ENL). Scand J Immunol. 1999 Nov;50(5):541-9. doi: 10.1046/j.1365-3083.1999.00622.x.
- Kahawita IP, Lockwood DN. Towards understanding the pathology of erythema nodosum leprosum. Trans R Soc Trop Med Hyg. 2008 Apr;102(4):329-37. doi: 10.1016/j.trstmh.2008.01.004. Epub 2008 Mar 3.
- Narayanan RB, Laal S, Sharma AK, Bhutani LK, Nath I. Differences in predominant T cell phenotypes and distribution pattern in reactional lesions of tuberculoid and lepromatous leprosy. Clin Exp Immunol. 1984 Mar;55(3):623-8.
- Sarno EN, Grau GE, Vieira LM, Nery JA. Serum levels of tumour necrosis factor-alpha and interleukin-1 beta during leprosy reactional states. Clin Exp Immunol. 1991 Apr;84(1):103-8.
- Barnes PF, Chatterjee D, Brennan PJ, Rea TH, Modlin RL. Tumor necrosis factor production in patients with leprosy. Infect Immun. 1992 Apr;60(4):1441-6. doi: 10.1128/iai.60.4.1441-1446.1992.
- Polycarpou A, Walker SL, Lockwood DN. A Systematic Review of Immunological Studies of Erythema Nodosum Leprosum. Front Immunol. 2017 Mar 13;8:233. doi: 10.3389/fimmu.2017.00233. eCollection 2017.
- Hossain D. Using methotrexate to treat patients with ENL unresponsive to steroids and clofazimine: a report on 9 patients. Lepr Rev. 2013 Mar;84(1):105-12.
- Kar BR, Babu R. Methotrexate in resistant ENL. Int J Lepr Other Mycobact Dis. 2004 Dec;72(4):480-2. doi: 10.1489/1544-581X(2004)722.0.CO;2.
- Rahul N, Sanjay KS, Singh S. Effectiveness of Methotrexate in prednisolone and thalidomide resistant cases of Type 2 lepra reaction: report on three cases. Lepr Rev. 2015 Dec;86(4):379-82. No abstract available.
- Sousa AL, Fava VM, Sampaio LH, Martelli CM, Costa MB, Mira MT, Stefani MM. Genetic and immunological evidence implicates interleukin 6 as a susceptibility gene for leprosy type 2 reaction. J Infect Dis. 2012 May 1;205(9):1417-24. doi: 10.1093/infdis/jis208. Epub 2012 Mar 29.
- Shannon E, Noveck R, Sandoval F, Kamath B, Kearney M. Thalidomide suppressed interleukin-6 but not tumor necrosis factor-alpha in volunteers with experimental endotoxemia. Transl Res. 2007 Nov;150(5):275-80. doi: 10.1016/j.trsl.2007.05.003. Epub 2007 Jun 26.
- Rajappa M, Rathika S, Munisamy M, Chandrashekar L, Thappa DM. Effect of treatment with methotrexate and coal tar on adipokine levels and indices of insulin resistance and sensitivity in patients with psoriasis vulgaris. J Eur Acad Dermatol Venereol. 2015 Jan;29(1):69-76. doi: 10.1111/jdv.12451. Epub 2014 Mar 25.
- Martiniuk F, Giovinazzo J, Tan AU, Shahidullah R, Haslett P, Kaplan G, Levis WR. Lessons of leprosy: the emergence of TH17 cytokines during type II reactions (ENL) is teaching us about T-cell plasticity. J Drugs Dermatol. 2012 May;11(5):626-30.
- Li Y, Jiang L, Zhang S, Yin L, Ma L, He D, Shen J. Methotrexate attenuates the Th17/IL-17 levels in peripheral blood mononuclear cells from healthy individuals and RA patients. Rheumatol Int. 2012 Aug;32(8):2415-22. doi: 10.1007/s00296-011-1867-1. Epub 2011 Jun 21.
- Reinhold-Keller E, de Groot K. Use of methotrexate in ANCA-associated vasculitides. Clin Exp Rheumatol. 2010 Sep-Oct;28(5 Suppl 61):S178-82. Epub 2010 Oct 28.
- Marzano AV, Ishak RS, Saibeni S, Crosti C, Meroni PL, Cugno M. Autoinflammatory skin disorders in inflammatory bowel diseases, pyoderma gangrenosum and Sweet's syndrome: a comprehensive review and disease classification criteria. Clin Rev Allergy Immunol. 2013 Oct;45(2):202-10. doi: 10.1007/s12016-012-8351-x.
- Davatchi F, Shams H, Shahram F, Nadji A, Chams-Davatchi C, Sadeghi Abdollahi B, Faezi T, Akhlaghi M, Ashofteh F. Methotrexate in ocular manifestations of Behcet's disease: a longitudinal study up to 15 years. Int J Rheum Dis. 2013 Oct;16(5):568-77. doi: 10.1111/1756-185X.12139. Epub 2013 Jul 4.
- Warren RB, Griffiths CE. The potential of pharmacogenetics in optimizing the use of methotrexate for psoriasis. Br J Dermatol. 2005 Nov;153(5):869-73. doi: 10.1111/j.1365-2133.2005.06880.x.
- Warren RB, Griffiths CE. Systemic therapies for psoriasis: methotrexate, retinoids, and cyclosporine. Clin Dermatol. 2008 Sep-Oct;26(5):438-47. doi: 10.1016/j.clindermatol.2007.11.006.
- Dalrymple JM, Stamp LK, O'Donnell JL, Chapman PT, Zhang M, Barclay ML. Pharmacokinetics of oral methotrexate in patients with rheumatoid arthritis. Arthritis Rheum. 2008 Nov;58(11):3299-308. doi: 10.1002/art.24034.
- Kaur I, Dogra S, Narang T, De D. Comparative efficacy of thalidomide and prednisolone in the treatment of moderate to severe erythema nodosum leprosum: a randomized study. Australas J Dermatol. 2009 Aug;50(3):181-5. doi: 10.1111/j.1440-0960.2009.00534.x. Erratum In: Australas J Dermatol. 2009 Nov;50(4):307.
- Warren RB, Weatherhead SC, Smith CH, Exton LS, Mohd Mustapa MF, Kirby B, Yesudian PD. British Association of Dermatologists' guidelines for the safe and effective prescribing of methotrexate for skin disease 2016. Br J Dermatol. 2016 Jul;175(1):23-44. doi: 10.1111/bjd.14816. No abstract available. Erratum In: Br J Dermatol. 2017 Jun;176(6):1678.
- World Health Organization. WHO Expert Committee on Leprosy. World Health Organ Tech Rep Ser. 2012;(968):1-61, 1 p following 61.
- Warren RB, Mrowietz U, von Kiedrowski R, Niesmann J, Wilsmann-Theis D, Ghoreschi K, Zschocke I, Falk TM, Blodorn-Schlicht N, Reich K. An intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis (METOP): a 52 week, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Feb 4;389(10068):528-537. doi: 10.1016/S0140-6736(16)32127-4. Epub 2016 Dec 22.
- Reich K, Langley RG, Papp KA, Ortonne JP, Unnebrink K, Kaul M, Valdes JM. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. N Engl J Med. 2011 Oct 27;365(17):1586-96. doi: 10.1056/NEJMoa1010858.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2023
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
November 29, 2018
First Submitted That Met QC Criteria
December 13, 2018
First Posted (Actual)
December 14, 2018
Study Record Updates
Last Update Posted (Actual)
March 13, 2023
Last Update Submitted That Met QC Criteria
March 10, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Skin Diseases
- Immune System Diseases
- Hypersensitivity
- Skin Manifestations
- Dermatitis
- Drug-Related Side Effects and Adverse Reactions
- Drug Eruptions
- Drug Hypersensitivity
- Erythema
- Erythema Nodosum
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Prednisolone
- Methotrexate
Other Study ID Numbers
- 15762
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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