11 completed, 4 terminated, 2 recruiting, 2 unknown. 19 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 19 | Completed 11, Terminated 4, Recruiting 2, Unknown 2 |
| Phase 2 | 2 | Completed 1, Recruiting 1 |
Follow Leflunomide: new trials by email Literature Review of Leflunomide trials Research Report on Leflunomide
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| The Effect of Nicorandil on Rheumatoid Arthritis Patients Nicorandil Oral Tablet, Placebo, conventional synthetic antirheumatic drugs (cDMARDs) - Rheumatoid Arthritis (RA) | Phase 2 / Phase 3 | Recruiting | Ain Shams University | 70 | 2026-09-06 | 2026-09-16 |
| Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis Prednisolone, Sulfasalazine, Leflunomide - Psoriatic Arthritis, Withdrawal | Phase 3 | Unknown | University of Erlangen-Nürnberg Medical School | 270 | 2020-10-19 | 2022-11-14 |
| Targeting de Novo Pyrimidine Biosynthesis by Leflunomide for the Treatment of COVID-19 Virus Disease leflunomide - COVID-19 | Phase 3 | Completed | Ashford and St. Peter's Hospitals NHS Trust | 178 | 2020-09-16 | 2023-02-27 |
| Treatment With Leflunomide in Patients With Polymyalgia Rheumatica Leflunomide 20 mg, Prednisolone - Polymyalgia Rheumatica | Phase 3 | Unknown | Elisabeth Brouwer | 94 | 2019-03-01 | 2019-06-03 |
| Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy Methotrexate, Leflunomide, Hydroxychloroquine - Rheumatoid Arthritis | Phase 3 | Terminated | Jawaharlal Institute of Postgraduate Medical Education & Research | 136 | 2016-09-01 | 2021-07-27 |
| A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA) Sarilumab, Sulfasalazine, Leflunomide - Rheumatoid Arthritis | Phase 3 | Completed | Sanofi | 91 | 2015-02-01 | 2018-01-30 |
| To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis Sarilumab, Auto-Injector Device (AID), Pre-filled Syringe (PFS) - RA | Phase 3 | Completed | Sanofi | 217 | 2014-03-01 | 2017-06-20 |
| A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis Azathioprine, Chloroquine, Hydroxychloroquine - Rheumatoid Arthritis | Phase 3 | Completed | Hoffmann-La Roche | 100 | 2013-11-20 | 2018-11-13 |
| To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) sarilumab SAR153191 (REGN88), tocilizumab, hydroxychloroquine - Rheumatoid Arthritis | Phase 3 | Completed | Sanofi | 202 | 2013-03-01 | 2017-06-26 |
| To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) Sarilumab, placebo, hydroxychloroquine - Rheumatoid Arthritis | Phase 3 | Completed | Sanofi | 546 | 2012-10-01 | 2017-08-08 |
| The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy Azathioprine, Leflunomide - Myasthenia Gravis | Phase 3 | Completed | First Affiliated Hospital, Sun Yat-Sen University | 290 | 2012-09-01 | 2022-04-14 |
| A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients tacrolimus capsule, tacrolimus placebo, leflunomide tablet - Lupus Nephritis | Phase 3 | Terminated | Astellas Pharma Inc | 84 | 2011-04-01 | 2014-10-17 |
| Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response Methotrexate, Abatacept, Adalimumab - Rheumatoid Arthritis | Phase 3 | Recruiting | University of Nebraska | 400 | 2007-12-10 | 2026-06-17 |
| Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid Arthritis leflunomide - Arthritis, Rheumatoid | Phase 3 | Completed | Sanofi | 124 | 2007-12-01 | 2010-10-13 |
| Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED) infliximab, DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89. - Rheumatoid Arthritis | Phase 3 | Terminated | Merck Sharp & Dohme LLC | 8 | 2007-06-01 | 2017-04-12 |
| A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT) Leflunomide, Methotrexate, Ocrelizumab - Rheumatoid Arthritis | Phase 3 | Terminated | Genentech, Inc. | 836 | 2007-05-15 | 2019-08-12 |
| Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis Leflunomide, Methotrexate-Sulfasalazine-Hydroxychloroquine, Leflunomide-Sulfasalazine-Hydroxychloroquine - Rheumatoid Arthritis | Phase 3 | Completed | University of Nebraska | 69 | 2001-03-27 | 2023-10-02 |
| Mitoxantrone and Prednisone With or Without Leflunomide in Treating Patients With Stage IV Prostate Cancer leflunomide, mitoxantrone hydrochloride, prednisone - Prostate Cancer | Phase 2 / Phase 3 | Completed | Pfizer | 1999-08-01 | 2012-09-11 | |
| SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma Multiforme leflunomide, procarbazine hydrochloride - Brain and Central Nervous System Tumors | Phase 3 | Completed | Pfizer | 1998-02-01 | 2012-09-11 |
Arthritis, Rheumatoid (11) · Arthritis, Psoriatic (1) · Autoimmune Diseases (1) · Brain Neoplasms (1) · COVID-19 (1) · Central Nervous System Neoplasms (1) · Glioblastoma (1) · Gliosarcoma (1) · Inflammation (1) · Lupus Nephritis (1) · Myasthenia Gravis (1) · Nephritis (1) · Polymyalgia Rheumatica (1) · Prostatic Neoplasms (1)
Sanofi (5) · Pfizer (2) · University of Nebraska (2) · Ain Shams University (1) · Ashford and St. Peter's Hospitals NHS Trust (1) · Astellas Pharma Inc (1) · Elisabeth Brouwer (1) · First Affiliated Hospital, Sun Yat-Sen University (1) · Genentech, Inc. (1) · Hoffmann-La Roche (1) · Jawaharlal Institute of Postgraduate Medical Education & Research (1) · Merck Sharp & Dohme LLC (1) · University of Erlangen-Nürnberg Medical School (1)
United States (8) · Czechia (4) · Italy (4) · Mexico (4) · Poland (4) · Argentina (3) · Brazil (3) · Canada (3) · Germany (3) · Hungary (3) · Israel (3) · Netherlands (3) · Romania (3) · Russia (3) · Spain (3)
James R O'Dell, MD (2) · Alison L. Hannah, MBBS (1) · E.M. Colin (1) · Elisabeth Brouwer (1) · Gilles Perdriset (1) · Isaac John (1) · Mack H. Mabry, MD (1) · May A. Shawky, Assoc. Prof. (1) · Nagwa A. Sabri, Professor (1) · Pooja Belani, MD (1) · Sharma Shashank, PI (1) · Vir S Negi, DM (1)
PMID 34519964, PMID 22389919, PMID 23401601, PMID 24498318, PMID 27860410, PMID 28326189, PMID 29209946, PMID 29244149, PMID 29556418, PMID 30590833, PMID 30649524, PMID 30877216, PMID 32453485, PMID 32522251, PMID 32907617, PMID 33871596, PMID 34586472, PMID 36008838, PMID 36413080, PMID 37055207
2005 (1)