A Phase 3 interventional study of Methotrexate and Abatacept in Rheumatoid Arthritis, sponsored by University of Nebraska. Recruiting at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by University of Nebraska · Phase 3, Interventional, and Treatment
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Among 113 studies testing methotrexate in Arthritis, Rheumatoid — 8 open to participants now, 10 under way, 2 of them phase 3. Methotrexate · Arthritis, Rheumatoid.
Among the 113 studies testing methotrexate in Arthritis, Rheumatoid, this one is the 20th largest by planned enrollment, is one of 9 that started in 2007, is one of 47 in phase 3, and was the 79th registered.
3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.
Browse Arthritis, Rheumatoid studies →8 of the 113 studies testing methotrexate in Arthritis, Rheumatoid are open now, in 5 countries. Recruiting first, the newest first:
NYU Langone Health · Sites in United States
Ages 18+
Keio University · Sites in Japan
Ages 18+
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–65
Konkuk University Medical Center · Sites in Korea, Republic of
Ages 19+
Medical University of Vienna · Sites in Austria
Ages 18–99
By country, each count listing its studies:
Methotrexate: first FDA approval 1953 (METHOTREXATE SODIUM), first EMA approval 2016. What it is approved for, and how studies give it, is on its page →
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
113 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 12 · Phase 3 48 · Phase 4 38
First in 1998; this study’s year is marked. 9 started in 2007.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 400 is above the median of 95 across 2,221 interventional studies indexed under Arthritis, Rheumatoid.
Median enrollment 130 across the 113 interventional studies. Of the 93 that completed or were terminated, 58 (62%) have results posted.
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84 of 113 have an industry lead sponsor. The 10 most frequent:
University of Nebraska is the lead sponsor of 496 studies on the registry; 66 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
University of Nebraska has 8 studies filed under Arthritis, Rheumatoid — fewer than ten, so there is no comparison to draw.
3 of the studies testing methotrexate in Arthritis, Rheumatoid that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05353829Region VästerbottenMethotrexate in Patients with Early Rheumatoid Arthritis | 2026-12-31 |
| NCT06590090XBiotech, Inc.Natrunix in Combination With Methotrexate for Rheumatoid Arthritis Treatment | 2027-01-15 |
| NCT06649136Medical University of ViennaMethMax Trial: MAXimising the METHotrexate Therapy Potential in Patients With Active Rheumatoid Arthritis | 2027-06-07 |
Add all 3 to your calendar (.ics) → With an account.
Among the 113 studies testing methotrexate in Arthritis, Rheumatoid, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs (NSAIDS), glucocorticoids, and disease-modifying anti-rheumatic drugs (DMARDs), including biologics. Methotrexate (MTX) is the DMARD of choice in the treatment of RA, because it has been shown to be both well-tolerated and effective in achieving clinical response and slowing radiographic progression of disease. However, this drug alone results in remissions in only a small subset of patients and reliable predictors of DMARD response have yet to be identified.
This study is open-label of 16-weeks duration to identify factors that help predict clinical responses to disease-modifying antirheumatic drugs (DMARD) therapies for rheumatoid arthritis (RA) participants. All participants will receive a starting dose of DMARD medication(s) which may be adjusted by the investigator as needed. If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator. Necessary withdrawals prior to week 16 visits will be considered end of study. Otherwise, end of study data as well as study serum will be collected at week 16. A portion of the blood collected at baseline, week 8 and week 16 for the optional addendum portion of the study is for future research and will be utilized attempting to look to detect the generation of superoxide radicals. These radicals have been shown to be associated with inflammation and may correlate with the progression of RA, which if confirmed, should decrease the levels of these radicals signaling response to treatment.
Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs (NSAIDS), glucocorticoids, and disease-modifying anti-rheumatic drugs (DMARDs), including biologics. Methotrexate (MTX) is the DMARD of choice in the treatment of RA, because it has been shown to be both well-tolerated and effective in achieving clinical response and slowing radiographic progression of disease. However, this drug alone results in remissions in only a small subset of patients and reliable predictors of DMARD response have yet to be identified.
Investigators have examined the discriminatory characteristics of several clinical and biologic parameters in predicting treatment response (at least 50% improvement based on American College of Rheumatology criteria), including rheumatoid factor (RF) isotypes (particularly Immunoglobulin A (IgA) and Immunoglobulin M (IgM), matrix metalloproteinase (MMP)-3, human leukocyte antigen-DR isotope (HLA-DRB1) shared epitope (SE)-containing alleles, C-reactive protein, and interleukin (IL)-1.
The purpose of the study is to prospectively gather information on participants with rheumatoid arthritis (RA) and their response to disease-modifying antirheumatic drugs (DMARD) therapy. Specifically, to evaluate the efficacy of DMARD therapy as defined by attaining American College of Rheumatology 50 (ACR50) response after 16 weeks of therapy and to identify predictors of DMARD response, such as genetic factors, serological factors or co-morbid conditions. A maximum of 400 rheumatoid arthritis (RA) participants will be enrolled in this 16-week, open-label study. Adult males and females will be enrolled, but RA is approximately three times more common in females.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosed rheumatoid arthritis (RA) with 4 of 7 American College of Rheumatology criteria
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive methotrexate therapy for rheumatoid arthritis (RA) treatment.
Drug: Methotrexate
Participants will receive abatacept therapy for rheumatoid arthritis (RA) treatment.
Drug: Abatacept
Participants will receive adalimumab therapy for rheumatoid arthritis (RA) treatment.
Drug: Adalimumab
Participants will receive azathioprine therapy for rheumatoid arthritis (RA) treatment.
Drug: Azathioprine
Participants will receive barcitinib therapy for rheumatoid arthritis (RA) treatment.
Drug: Baricitinib
Participants will receive certolizumab therapy for rheumatoid arthritis (RA) treatment.
Drug: Certolizumab
Participants will receive etanercept therapy for rheumatoid arthritis (RA) treatment.
Drug: Etanercept
Participants will receive golimumab therapy for rheumatoid arthritis (RA) treatment.
Drug: Golimumab
Participants will receive hydroxychloroquine therapy for rheumatoid arthritis (RA) treatment.
Drug: Hydroxychloroquine
Participants will receive infliximab therapy for rheumatoid arthritis (RA) treatment.
Drug: Infliximab
Participants will receive leflunomide therapy for rheumatoid arthritis (RA) treatment.
Drug: Leflunomide
Participants will receive minocycline therapy for rheumatoid arthritis (RA) treatment.
Drug: Minocycline
Participants will receive rituximab therapy for rheumatoid arthritis (RA) treatment.
Drug: Rituximab
Participants will receive sarilumab therapy for rheumatoid arthritis (RA) treatment.
Drug: Sarilumab
Participants will receive sulfasalazine therapy for rheumatoid arthritis (RA) treatment.
Drug: Sulfasalazine
Participants will receive tofacitinib therapy for rheumatoid arthritis (RA) treatment.
Drug: Tofacitinib
Starting dose of Methotrexate of 15 mg once a week plus folic acid 1mg daily.
Also known as: Methotrexate (MTX)
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Orencia
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Humira
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Imuran
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Olimuant
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Cimzia
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Enbrel
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Simponi
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Plaquenil
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Remicade
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Arava
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Minocin
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Rituxin
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Kevzara
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Azulfidine
Starting dose may be adjusted as needed at investigator's discretion.
Also known as: Xeljanz
Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis
The efficacy of the disease-modifying antirheumatic drugs (DMARD) in the study will be determined using the American College of Rheumatology 50 (ACR50). This is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time frame: 16 weeks
Genetic factors as Predictors of Disease-modifying Antirheumatic Drugs Response
Based on American College of Rheumatology 50 (ACR50) composite measure after 16 weeks of treatment, the number of participants will be determined that have genetic factors, such as the shared epitope, that demonstrate a 50% improvement in the number of tender and swollen joints, and a 50% improvement in three of five criteria: patient global assessment, physician global assessment, functional ability measure (most often Health Assessment Questionnaire/HAQ), visual analog pain scale and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time frame: 16 weeks
Serological Factors as Predictors of Disease-modifying Antirheumatic Drugs Response
Based on American College of Rheumatology 50 (ACR50) composite measure after 16 weeks of treatment, the number of participants will be determined that have serological factors, such as cyclic citrullinated peptide (CCP) isotypes, that demonstrate a 50% improvement in the number of tender and swollen joints, and a 50% improvement in three of five criteria: patient global assessment, physician global assessment, functional ability measure (most often Health Assessment Questionnaire/HAQ), visual analog pain scale and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time frame: 16 weeks
Co-morbid Conditions as Predictors of Disease-modifying Antirheumatic Drugs Response
Based on American College of Rheumatology 50 (ACR50) composite measure after 16 weeks of treatment, the number of participants will be determined that have co-morbid conditions, such as periodontal disease, that demonstrate a 50% improvement in the number of tender and swollen joints, and a 50% improvement in three of five criteria: patient global assessment, physician global assessment, functional ability measure (most often Health Assessment Questionnaire/HAQ), visual analog pain scale and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time frame: 16 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2007 (actual). Primary completion is estimated for Mar 2028, 243 months after the start.
Of 148 phase 3 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 40. This study's planned 243 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Methotrexate · Abatacept · Adalimumab · Azathioprine · Baricitinib · Certolizumab Pegol · Etanercept · Golimumab · Hydroxychloroquine · Infliximab · Leflunomide · Minocycline · Rituximab · Sarilumab · Sulfasalazine · Tofacitinib