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Home › Medications › methotrexate

methotrexate

31 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials of methotrexate

313 trials tracked of methotrexate: 155 in phase 3 or 4 and 68 with published results. The most-cited published study has 1723 citations.

313Trials tracked
155Phase 3 & 4
0Recruiting
68With published results
Phase distribution
Phase 4 42 Phase 3 113 Phase 2 137 Phase 1 10 Other / NA 11
  1. Phase 3 Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040) Completed · 1,723 cited
  2. Phase 3 Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141) Completed · 812 cited
  3. Phase 4 Mechanism of Action Study for Psoriasis Completed · 728 cited
  4. Phase 3 TAC/MTX vs. TAC/MMF/PTCY for Prevention of Graft-versus-Host Disease and Microbiome and Immune Reconstitution Study (BMT CTN 1703/1801) Completed · 595 cited
  5. Phase 3 A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study) Completed · 593 cited
  6. Phase 3 Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma Completed · 552 cited
Show 44 more trials
  1. Phase 3 Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) Completed · 339 cited
  2. Phase 3 Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients Completed · 270 cited
  3. Phase 3 Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia Completed · 256 cited
  4. Phase 3 05-001: Treatment of Acute Lymphoblastic Leukemia in Children Completed · 243 cited
  5. Phase 3 Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia Completed · 236 cited
  6. Phase 3 Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia in Complete Remission Completed · 227 cited
  7. Phase 3 Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis Completed · 218 cited
  8. Phase 3 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) Completed · 214 cited
  9. Phase 4 Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate Completed · 183 cited
  10. Phase 3 Calcineurin Inhibitor-Free Interventions BMT CTN 1301 for Prevention of Graft-versus-Host Disease (BMT CTN 1301) Completed · 179 cited
  11. Phase 3 A Study in Moderate to Severe Rheumatoid Arthritis Completed · 168 cited
  12. Phase 3 A Study in Participants With Moderate to Severe Rheumatoid Arthritis Completed · 168 cited
  13. Phase 4 Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis Completed · 165 cited
  14. Phase 3 A Double Blind Study in Pediatric Subjects With Chronic Plaque Psoriasis, Studying Adalimumab vs. Methotrexate Completed · 153 cited
  15. Phase 4 MTX Discontinuation and Vaccine Response Completed · 141 cited
  16. Phase 3 An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA) Completed · 136 cited
  17. Phase 3 A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) Treatment Completed · 131 cited
  18. Phase 4 Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis. Completed · 130 cited
  19. Phase 3 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) Completed · 128 cited
  20. Phase 3 A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy Completed · 106 cited
  21. Phase 3 Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma Completed · 102 cited
  22. Phase 4 Triple Combination Therapy in High Risk Crohn's Disease (CD) Completed · 93 cited
  23. Phase 3 Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations Completed · 87 cited
  24. Phase 4 Treatments Against RA and Effect on FDG-PET/CT Completed · 77 cited
  25. Phase 4 IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA Completed · 72 cited
  26. Phase 4 Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout Completed · 67 cited
  27. Phase 3 Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients Completed · 64 cited
  28. Phase 3 Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma Completed · 61 cited
  29. Phase 3 LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy Completed · 59 cited
  30. Phase 4 Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout Completed · 58 cited
  31. Phase 3 A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) Completed · 55 cited
  32. Phase 3 A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate Completed · 55 cited
  33. Phase 3 A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis Completed · 54 cited
  34. Phase 4 Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis Completed · 53 cited
  35. Phase 3 Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia Completed · 53 cited
  36. Phase 3 Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia Completed · 50 cited
  37. Phase 3 A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX Completed · 50 cited
  38. Phase 3 Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia Completed · 48 cited
  39. Phase 3 A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI) Completed · 47 cited
  40. Phase 3 Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy Completed · 45 cited
  41. Phase 3 A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment Completed · 44 cited
  42. Phase 3 Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis Completed · 41 cited
  43. Phase 3 A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis Completed · 38 cited
  44. Phase 3 A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent Completed · 38 cited

Showing the 50 most-cited and recently-updated of 313 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Biological DMARDs show marginal patient-reported outcome benefits over conventional therapy in early rheumatoid arthritis
Rheumatology RCT
Biological DMARDs show marginal patient-reported outcome benefits over conventional therapy in early rheumatoid arthritis Early rheumatoid arthritis patients report similar symptom relief with different treatment approaches
This open-label randomized trial in 795 newly diagnosed, DMARD-naïve RA patients compared three biological DMARDs plus methotrexate against …
In early rheumatoid arthritis, patients reported similar pain relief and quality-of-life improvements whether they started with conventional…
Apr 9, 2026
Post-hoc analysis of RCTs and cohorts identifies predictors of remission in ACPA-positive early RA treated with abatacept plus methotrexate or methotrexate alone
Rheumatology RCT
Post-hoc analysis of RCTs and cohorts identifies predictors of remission in ACPA-positive early RA treated with abatacept plus methotrexate or methotrexate alone Early disease activity and response predict remission in ACPA-positive rheumatoid arthritis patients
This post-hoc analysis of randomized controlled trials and an observational cohort evaluated predictors of DAS28-CRP remission in ACPA-posit…
Only early disease activity and treatment response predict remission in ACPA-positive rheumatoid arthritis, while genetic markers and imagin…
Apr 8, 2026
Case report: Orelabrutinib-rituximab with intravitreal methotrexate shows response in primary vitreoretinal lymphoma
Oncology Sys. Review
Case report: Orelabrutinib-rituximab with intravitreal methotrexate shows response in primary vitreoretinal lymphoma Can a new drug combination help treat a rare eye cancer?
A case report with literature review describes one patient with primary vitreoretinal lymphoma (PVRL) treated with orelabrutinib and rituxim…
A new drug combination improved vision and controlled tumors in a patient with a rare eye cancer, with no reported side effects.
Frontiers Apr 7, 2026
Machine learning model predicts delayed methotrexate clearance in pediatric osteosarcoma patients
Pediatrics Cohort
Machine learning model predicts delayed methotrexate clearance in pediatric osteosarcoma patients Study develops model to predict delayed drug clearance in pediatric bone cancer
A retrospective cohort study of 181 pediatric osteosarcoma patients treated with high-dose methotrexate developed a web-based prediction mod…
A new computer model predicts which children with bone cancer face delayed drug clearance, helping doctors monitor treatment risks before co…
Frontiers Apr 6, 2026
FPGS Gene Variants Linked to Methotrexate Efficacy and Toxicity in Rheumatoid Arthritis
Rheumatology Meta-analysis
FPGS Gene Variants Linked to Methotrexate Efficacy and Toxicity in Rheumatoid Arthritis Could your genes explain why methotrexate works better for some people?
A meta-analysis of 2345 rheumatoid arthritis patients on methotrexate found FPGS polymorphisms rs10106 and rs1544105 were significantly asso…
Your genes might explain why methotrexate works better for some rheumatoid arthritis patients but also raises their risk of harmful side eff…
Apr 5, 2026
Case report tracks urinary ADEV GluN1 levels in anti-NMDAR encephalitis patient during treatment
Neurology
Case report tracks urinary ADEV GluN1 levels in anti-NMDAR encephalitis patient during treatment Single case study tracks brain inflammation marker in urine during treatment
A case report of a single female patient with anti-NMDAR encephalitis analyzed urinary astrocyte-derived extracellular vesicles (ADEVs).
Urine tests tracked brain inflammation changes in a patient with anti-NMDAR encephalitis, showing protein levels dropped over treatment and …
medRxiv Apr 4, 2026
Meta-analysis finds nausea in 24% and abdominal pain in 20% of RA patients on methotrexate
Rheumatology Meta-analysis
Meta-analysis finds nausea in 24% and abdominal pain in 20% of RA patients on methotrexate How common is nausea and stomach pain for RA patients on methotrexate?
A systematic review and meta-analysis of 37 studies involving 19,986 adult RA patients on methotrexate found pooled prevalence rates of 24.3…
Nearly one in five rheumatoid arthritis patients taking methotrexate experience nausea or stomach pain, with about 8.5% stopping the drug du…
Apr 1, 2026