Erythema Nodosum LeprosumMaPsNCT03775460
Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum
A study testing Methotrexate and Prednisolone in people with Erythema Nodosum Leprosum, run by London School of Hygiene and Tropical Medicine at 7 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Erythema Nodosum Leprosum
- What is being tested?
- Methotrexate and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 15 Jan 2023to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
About this study
Official title: 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.
Read the 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.
- Conditions
- Erythema Nodosum Leprosum
- Being tested
- Methotrexate, Placebo, Prednisolone
- Keywords
- Erythema Nodosum Leprosum, ENL, corticosteroids, Methotrexate, ENL severity scale, quality of life, Leprosy
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Participants in the intervention group will receive methotrexate along side prednisolone
PlaceboDrug
Participants in the control arm will receive placebo along side prednisolone
PrednisoloneDrug
Participants in both arm will receive prednisolone, which will be the same dosage: 40 mg (initial dose) decreasing dosage for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | 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. Receives: Drug: Placebo; Drug: Prednisolone |
| intervention | Experimental | 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. Receives: Drug: Methotrexate; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals free from Erythema Nodosum Leprosum (ENL) flares in 24 weeks
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.
Measured: During the first 24 weeks
Proportion of individuals free from ENL flares in 48 weeks
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
Measured: During first 48 weeks
Secondary outcomes (11)
Change in ENLIST ENL severity scale score (EESS)
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
Measured: 60 weeks
Quality of life changes: 36- Item Short Form (SF-36) questionnaire
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.
Measured: at 24 and 48 weeks
Quality of life changes regarding skin condition: Dermatology life quality Index (DLQI)
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.
Measured: at 24 and 48 weeks
Proportion of individuals free from ENL flares at 60 weeks
Proportion of individuals who do not require prednisolone at 60 weeks
Measured: 60 weeks
ENL flares per individual up to 60 weeks
Number of flares of ENL per individual requiring additional prednisolone up to 60 weeks
Measured: 60 weeks
Severity of ENL flares
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
Measured: 60 weeks
Time to the first flare of ENL
How long it takes to a participant who has an ENL flare to present with first episode of flare after enrolment
Measured: 60 weeks
Adverse effects
Proportion of individuals with treatment related adverse effects
Measured: 60 weeks
Quality of life at 60 weeks: SF-36 questionnaire
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
Measured: 60 weeks
Quality of life at 60 weeks regarding skin condition: Dermatology Life Quality Index (DLQI) questionnaires
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.
Measured: 60 weeks
Individuals free from ENL flares in 60 weeks
Proportion of individuals who have not required additional prednisolone in the 60 weeks of the trial
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start15 Jan 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Erythema Nodosum LeprosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Soetomo General Hospital, The Leprosy Mission Trust, India, Alert Hospital, Ethiopia, The Leprosy Mission Bangladesh, Bombay Leprosy Project, India, Oswaldo Cruz Foundation, Leprosy Research Initiative, The Leprosy Mission Nepal
- Responsible party
- Sponsor
- Investigators
- Stephen Walker, MD, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775460
- Sponsor's protocol ID
- 15762
- Acronym
- MaPs
- Status last verified
- Oct 2024
- First submitted
- 29 Nov 2018
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26919207Pocaterra 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.
PubMed 16687695Kumar 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.
PubMed 15301592Chandler 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.
PubMed 25590638Walker 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.
PubMed 24625394Walker SL, Waters MF, Lockwood DN. The role of thalidomide in the management of erythema nodosum leprosum. Lepr Rev. 2007 Sep;78(3):197-215.
PubMed 18035771Walker 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.
PubMed 28671966Wemambu 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.
PubMed 4186599Moraes 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.
PubMed 10564558Kahawita 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.
PubMed 18313706Narayanan 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.
PubMed 6423326Sarno 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.
PubMed 2015700Barnes 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.
PubMed 1548069Polycarpou 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.
PubMed 28348555Hossain 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.
PubMed 23741889
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum (MaPS in ENL
- ClinicalTrials.gov ID
- NCT03775460
- Acronym / sponsor ID
- MaPs / 15762
- Conditions
- Erythema Nodosum Leprosum
- Keywords
- Erythema Nodosum Leprosum, ENL, corticosteroids, Methotrexate, ENL severity scale, quality of life, Leprosy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Dr. Soetomo General Hospital, The Leprosy Mission Trust, India, Alert Hospital, Ethiopia, The Leprosy Mission Bangladesh, Bombay Leprosy Project, India, Oswaldo Cruz Foundation, Leprosy Research Initiative, The Leprosy Mission Nepal
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Drug: Placebo, Drug: PrednisoloneParticipants 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. |
| intervention | Experimental | Drug: Methotrexate, Drug: PrednisoloneParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateParticipants in the intervention group will receive methotrexate along side prednisolone | Drug | intervention |
| PlaceboParticipants in the control arm will receive placebo along side prednisolone | Drug | control |
| PrednisoloneParticipants in both arm will receive prednisolone, which will be the same dosage: 40 mg (initial dose) decreasing dosage for 20 weeks | Drug | control, intervention |
Primary outcome
Proportion of individuals free from Erythema Nodosum Leprosum (ENL) flares in 24 weeks
Time frame: During the first 24 weeks
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.
Proportion of individuals free from ENL flares in 48 weeks
Time frame: During first 48 weeks
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
11 secondary outcomes
Change in ENLIST ENL severity scale score (EESS)
Time frame: 60 weeks
Quality of life changes: 36- Item Short Form (SF-36) questionnaire
Time frame: at 24 and 48 weeks
Quality of life changes regarding skin condition: Dermatology life quality Index (DLQI)
Time frame: at 24 and 48 weeks
Proportion of individuals free from ENL flares at 60 weeks
Time frame: 60 weeks
ENL flares per individual up to 60 weeks
Time frame: 60 weeks
Severity of ENL flares
Time frame: 60 weeks
Time to the first flare of ENL
Time frame: 60 weeks
Adverse effects
Time frame: 60 weeks
Quality of life at 60 weeks: SF-36 questionnaire
Time frame: 60 weeks
Quality of life at 60 weeks regarding skin condition: Dermatology Life Quality Index (DLQI) questionnaires
Time frame: 60 weeks
Individuals free from ENL flares in 60 weeks
Time frame: 60 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Background: PubMed 26919207Lambert 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.
- Background: PubMed 16687695Pocaterra 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.
- Background: PubMed 15301592Kumar 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.
- Background: PubMed 25590638Chandler 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.
- Background: PubMed 24625394Walker 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.
- Background: PubMed 18035771Walker SL, Waters MF, Lockwood DN. The role of thalidomide in the management of erythema nodosum leprosum. Lepr Rev. 2007 Sep;78(3):197-215.
- Background: PubMed 28671966Walker 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.
- Background: PubMed 4186599Wemambu 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.
- Background: PubMed 10564558Moraes 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.
- Background: PubMed 18313706Kahawita 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.
- Background: PubMed 6423326Narayanan 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.
- Background: PubMed 2015700Sarno 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Walker, MD, PhD principal investigator
London School of Hygiene and Tropical Medicine
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methotrexate and Prednisolone in people with Erythema Nodosum Leprosum, run by London School of Hygiene and Tropical Medicine at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India, Bangladesh, Brazil, Ethiopia, Indonesia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of individuals free from Erythema Nodosum Leprosum (ENL) flares in 24 weeks (time frame: During the first 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03775460, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.