New combo therapy targets Hard-to-Treat rheumatoid arthritis
NCT ID NCT06301373
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding tofacitinib to standard methotrexate works better than methotrexate alone for people with active rheumatoid arthritis who have a specific 'myeloid-stromal' type. 130 adults will be randomly assigned to either the combo or methotrexate-only group for 12 weeks, then followed for 48 weeks. The main goal is to see if more people in the combo group achieve at least a 20% improvement in symptoms (ACR20).
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- methotrexate and tofacitinib (a JAK inhibitor)
- What this could lead to
- If successful, this could show that combining methotrexate with tofacitinib early on works better than methotrexate alone for people with a specific type of rheumatoid arthritis, leading to better disease control.
- What could go wrong
- This is a small, early-stage study (130 people) with no placebo group, so results may not apply to everyone. Tofacitinib has known risks like infections and blood clots, and the 12-week treatment period is short.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients were diagnosed according to the 1987 American College of Rheumatology or 2010 American College of Rheumatology/European League Against Rheumatism criteria * Patients had moderate or high disease activity * Patients had a synovial biopsy and with a myeloid-stromal pathotype * Patients with good compliance, willing to participate in this study and sign an informed consent form Exclusion Criteria: * Patient received conventional synthetic disease modifying anti-rheumatic drugs treatment in the first 12 weeks of randomization * Patient received biologic agents treatment in the first 6 months of randomization * Patient received Janus kinase inhibitor treatment before randomization * Patient with serious diseases under control (such as diabetes), serious respiratory diseases, serious chronic gastrointestinal diseases (such as active or recurrent gastrointestinal ulcers), serious blood system diseases (such as aplastic anemia, myelodysplastic syndrome) or any disease that can cause hemolysis or erythrocyte instability (such as malaria, hemolytic anemia) * Patients with moderate to severe congestive heart failure (New York Heart Association grade III or IV), or recent (within 6 months prior to screening) cerebrovascular accident, myocardial infarction, coronary stent implantation, or uncontrolled hypertension * Patients with blood routine WBC\<4.0 × 109/L, and/or Hb\<90g/L, and/or Plt\<100 × 109/L during the screening period * Patients with active chronic liver disease or abnormal liver function, AST, ALT, GGT, and TBIL are more than twice the upper limit of normal during the screening period * Patients with estimated glomerular filtration rate \<30ml/min during screening period * Patients with history of symptomatic herpes zoster infection (within the first 12 weeks of randomization), recurrent or disseminated (even if only once) herpes zoster or disseminated (even if only once) herpes simplex infection * Chest X-ray or CT examination indicates active tuberculosis, or latent tuberculosis (T-SPOT or TB-IGRA positive) without prophylactic tuberculosis treatment for at least 4 weeks * Patients woth hepatitis C virus ribonucleic acid (HCV-RNA) testing are higher than the lower limit of detection; Or positive for Treponema pallidum antibody (TP Ab); Or human immunodeficiency virus antibody (HIV Ab) positive during the selected period * Patients with hepatitis B surface antigen positive without prophylactic antiviral treatment * Patients with history of lymphoproliferative diseases, or possibly various signs or symptoms of lymphoproliferative diseases * Patients with any active malignant tumors or history of malignant tumors within the first 5 years, except for skin squamous or basal cell carcinoma, cervical carcinoma in situ, or breast ductal carcinoma in situ that has been treated and considered cured * Patients with history of thromboembolism, including deep vein thrombosis, pulmonary embolism, arterial thrombosis, etc., or high risk factors prone to thromboembolism (such as obesity, smoking, abnormal coagulation function, diabetes, long-term use of estrogen or use of compound hormonal contraceptives or hormone replacement therapy, long-term braking, etc., which are comprehensively judged by the investigator according to clinical evaluation) * Patients with undergone major surgery within the first 4 weeks of randomization, or is expected to undergo major surgery after enrollment; Or a history of chronic pain that may affect the evaluation of the study; Or have received organ transplantation before * Patients with history of mental illness, alcoholism, drug or other substance abuse * Pregnant women, lactating women, and men or women who plan to conceive in the near future * The researchers believe that there are any other factors that may affect the progress or evaluation of the results of this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Foshan Hopsital of Traditional Chinese Medicine
RECRUITINGFoshan, Guangdong, 528000, China
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Pu Ning Shi Ren Ming Yi Yuan
RECRUITINGJieyang, Guangdong, 515300, China
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Shenshan Medical Central, Memorial Hospital of Sun Yat-sen University
RECRUITINGShantou, Guangdong, 516621, China
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Sun Yat-sen Memorial Hospital
RECRUITINGGuangzhou, Guangdong, 510120, China
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The Affiliated Panyu Central Hospital of Guangzhou Medical University
RECRUITINGGuangzhou, Guangdong, 511400, China
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