Rheumatoid ArthritsPhase 3NCT07856511
A Study to Evaluate the Efficacy and Safety of Proximod in Patients With Rheumatoid Arthritis
A Phase 3 study testing Proximod in people with Rheumatoid Arthrits, run by Jiankuan (Suzhou) Biotechnology Company Limited.
Trial summary
This study is to evaluate the efficacy and safety of different doses of proximod in moderate-to-severe active rheumatoid arthritis subjects with inadequate response or intolerance to bDMARDs and/or tsDMARDs Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthrits
- What is being tested?
- Proximod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 590 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 30 Sep 2028
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the 2010 classification criteria for rheumatoid arthritis (RA) of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR), the diagnosis is made for RA and the disease duration at the screening visit is at least 3 months.
- Moderate to severe RA defined by 6 or more tender joints, 6 or more swollen joints (68- or 66-joint count), and an ESR of 28 mm/h or greater or hsCRP > 1.2 × upper limit of laboratory normal range (ULN).
- Before the first administration, the participants had received MTX treatment for at least 3 consecutive months, with a stable dose for at least 4 weeks (oral or parenteral MTX [10-25 mg/week; or for those who were intolerant to the maximum dose of ≥10 mg/week, a dose of ≥7.5 mg/week could be used]).
- The participants had previously received at least one form of bDMARDs and/or tsDMARDs, but the treatment was either ineffective or they experienced intolerability. Ineffectiveness is defined as: After continuous treatment with the same bDMARD or tsDMARD for at least 12 weeks, there is still persistent or recurrent disease activity of rheumatoid arthritis, or the initial clinical improvement achieved during the treatment subsequently weakens or disappears, and the study investigator determines that the expected treatment goal has not been reached, thus requiring discontinuation or replacement of the drug. Intolerance is defined as: Those who have actually received treatment with a certain bDMARD or tsDMARD in the past and permanently discontinued the treatment due to recorded adverse events related to the drug, abnormal and clinically significant laboratory tests, or other toxicities, and the study investigator determines that continued use or re-use of the drug is not appropriate. Those who discontinue the treatment due to intolerance do not require a treatment duration of at least 12 weeks.
- Participants used a stable dose of oral/inhaled prednisone (≤ 10 mg/day) or an equivalent dose of glucocorticoids 4 weeks before the first administration of the study drug, and were expected to continue using the original stable dose during the trial; or they had stopped using oral/inhaled glucocorticoids ≥ 2 weeks before the first administration.
- Participants used a stable dose of non-steroidal anti-inflammatory drugs or acetaminophen/paracetamol 4 weeks before the first administration of the study drug, and were expected to continue taking the original stable dose during the trial; or they had stopped using non-steroidal anti-inflammatory drugs or acetaminophen/paracetamol for ≥ 5 half-lives/2 days (whichever was the longer period).
- During the course of the study and within 9 months after the last administration of the study drug, all female and male participants of reproductive age must use appropriate contraceptive measures.
Who cannot join
- Known or suspected allergies to the study drug or any component of the study drug.
- The ACR functional classification is level IV.
- Those who have been bedridden for a long time or are confined to a wheelchair for a long period of time.
- The participants plan to undergo joint surgery or major surgeries during the treatment period.
- During the screening, if the participant's forced expiratory volume in one second (FEV1) or forced vital capacity (FVC) was lower than 70% of the predicted value, and the FEV1/FVC ratio was less than 0.70;
- During the 4 weeks prior to the first administration of the drug, the following medications or treatments were used: Glucocorticoids: Administration can be through intra-articular injection, at trigger points or tender points, within the joint capsule, within the tendon sheath, or by intramuscular or intravenous injection. Other DMARDs except MTX: including but not limited to minocycline, penicillamine, sulfasalazine, hydroxychloroquine, chloroquine, azathioprine, gold preparations, cyclophosphamide, Tripterygium wilfordii(Leigongteng), ilarimod. Immunosuppressive or immunomodulatory drugs: including but not limited to tacrolimus, cyclosporine, Pavlin(Total Glucosides of Paeony Capsules), mycophenolate mofetil, 6-mercaptopurine, etc. Interferons: including but not limited to interferon, intron A(Interferon alfa-2b injection), Rebetron, etc.; Imaging agents: technetium [99Tc] methylenediphosphonate injection; Opioid drugs: including but not limited to oxycodone, oxymorphone, fentanyl, levorphanol, buprenorphine, methadone, hydrocodone, morphine, pethidine; Oral traditional Chinese medicines for treating RA and other inflammatory response diseases (Appendix 9. Traditional Chinese patent medicines related to RA). Received live vaccines or attenuated live vaccines. Undergone major surgery.
Show all 23Show fewer
- Before the first administration of the study drug, any of the following drugs or treatments were used:
- Received integrin αV antibody or cell depletion therapy within 5 half-lives or within 3 months (whichever is longer).
- Used drugs that interact with the study drug within 5 half-lives or within 4 weeks (whichever is longer). See Table 12-3.
- Received JAK inhibitors and/or S1P receptor agonists within 5 half-lives or within 2 weeks (whichever is longer).
- Took oral or intravenous anti-infective drugs within 14 days.
- Have used any type of leukopoietic agents within the past 14 days.
- Used leflunomide within 12 weeks; if standard colestyramine (8g, 3 times daily) is used to elute leflunomide, it needs to be eluted for 11 days, and the eluting drug should be discontinued for ≥ 2 weeks before the first administration of the study drug.
- The withdrawal requirements for biologic disease-modifying antirheumatic drugs (bDMARDs) are shown in Table 12-4.
- Within 3 months prior to randomization:
- Has participated in any interventional clinical trials involving drugs or medical devices.
- Has donated blood and the volume of donation was ≥ 400 mL, or has received blood transfusion.
- Alcohol abuse (i.e., consumption of more than 14 standard units per week [a standard unit containing 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% liquor or 150 mL of wine]) or substance abuse was present at screening or had a history of alcohol abuse or substance abuse within 6 months before randomization.
- Patients with active tuberculosis, positive γ-interferon release assay (T-SPOT.TB or other γ-interferon release assay equivalent indicators) by chest CT examination during screening.
- Potential malignancy was present at the time of screening.
- Ophthalmologic studies, including fundus examination and optical coherence tomography, were abnormal and clinically relevant at screening, especially for participants with macular disorders and maculopathy.
- Participants who are pregnant or breastfeeding, or those who plan to become pregnant or breastfeed during the course of the study or within 9 months after the last administration of the drug.
- The investigator considered that there were any other factors that might affect the conduct of the study or the evaluation of outcomes.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Proximod Tablets in Moderate-to-Severe Active Rheumatoid Arthritis Subjects With Inadequate Response or Intolerance to bDMARDs and/or tsDMARDs
This study is to evaluate the efficacy and safety of different doses of proximod in moderate-to-severe active rheumatoid arthritis subjects with inadequate response or intolerance to bDMARDs and/or tsDMARDs
Read the detailed description
This study is divided into two phases and planned to recruit 590 patients. Phase I: To evaluate the efficacy of different doses of proximod tablets compared to placebo in patients with moderate to severe active rheumatoid arthritis who have poor response or intolerance to bDMARDs and/or tsDMARDs. After the last administration and efficacy assessment (Week 16) of the core treatment period for the last participant, the primary endpoint analysis of Phase I will be conducted to determine the optimal dose for Phase II. Phase II: Using ACR20 as the primary efficacy indicator, to confirm that proximod tablets are more effective than placebo in patients with moderate to severe active rheumatoid arthritis who have poor response or intolerance to bDMARDs and/or tsDMARDs.
- Conditions
- Rheumatoid Arthrits
- Being tested
- Placebo, Proximod
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
The placebo group will take drugs orally for 16 weeks, and then were randomly assigned to proximod dose 1 and proximod dose 2 for 36 weeks, in the meanwhile, proximod dose 1 group and proximod dose 2 group will continue taking drugs for the whole 52 weeks.
ProximodDrug
The placebo group will take drugs orally for 16 weeks, and then were randomly assigned to proximod dose 1 and proximod dose 2 for 36 weeks, in the meanwhile, proximod dose 1 group and proximod dose 2 group will continue taking drugs for the whole 52 weeks.
ProximodDrug
The placebo group will take drugs orally for 16 weeks, and then were randomly assigned to proximod dose 1 and proximod dose 2 for 36 weeks, in the meanwhile, proximod dose 1 group and proximod dose 2 group will continue taking drugs for the whole 52 weeks.
PlaceboDrug
The placebo group will take drugs orally for 16 weeks, and then switch to proximod for 36 weeks, in the meanwhile, proximod group will continue taking drugs for the whole 52 weeks.
ProximodDrug
The placebo group will take drugs orally for 16 weeks, and then switch to proximod for 36 weeks, in the meanwhile, proximod group will continue taking drugs for the whole 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Placebo | Placebo comparator | Placebo for 16 weeks + Proximod tablets dose 1/dose 2 for 36 weeks Receives: Drug: Placebo |
| Phase I: Proximod dose 1 | Experimental | Proximod tablets dose 1 for 52 weeks Receives: Drug: Proximod |
| Phase I: Proximod dose 2 | Experimental | Proximod tablets dose 2 for 52 weeks Receives: Drug: Proximod |
| Phase II: Placebo | Placebo comparator | Placebo for 16 weeks + Proximod tablets dose 1 or dose 2 for 36 weeks Receives: Drug: Placebo |
| Phase II: Proximod | Experimental | Proximod tablets dose 1 or dose 2 for 52 weeks Receives: Drug: Proximod |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20 response rate at week 16(Phase I and Phase II)
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 16
Measured: Week 16
Secondary outcomes (16)
ACR20 response rate(Phase I and Phase II)
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria
Measured: Week 2, Week 4, Week 8, week 12, Week 20, Week 24, Week 32, week 40, week 48, week 52 and week 60
ACR50 response rate(Phase I and Phase II)
Response rate of 50% improvement in American College of Rheumatology (ACR50) criteria
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
ACR70 response rate(Phase I and Phase II)
Response rate of 70% improvement in American College of Rheumatology (ACR70) criteria
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Change from baseline in SDAI score(Phase I and Phase II)
Change from baseline in SDAI(Simplified Disease Activity Index) score
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Change from baseline in CDAI score(Phase I and Phase II)
Change from baseline in CDAI(Clinical Disease Activity Index) score(Phase I and Phase II)
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Change from baseline in HAQ-DI score(Phase I and Phase II)
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Change from baseline in DAS28-CRP(Phase I and Phase II)
Change from baseline in DAS28-CRP(Disease Activity Score for 28-joint counts based on the c-reaction protein)
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Change from baseline in DAS28-ESR(Phase I and Phase II)
Change from baseline in DAS28-ESR(Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate)
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
DAS28-CRP<2.6 or≤3.2 proportion(Phase I and Phase II)
Disease Activity Score for 28-joint counts based on the c-reaction protein (DAS28-CRP) of less than 2.6 or equal to and less than 3.2
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
DAS28-ESR<2.6 or≤3.2 proportion(Phase I and Phase II)
Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate) of less than 2.6 or equal to and less than 3.2
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
The proportion of HAQ improvement(Phase I and Phase II)
The proportion of patients whose HAQ-DI (health assessment questionnaire disability index
) score decreased by at least 0.22 points and 0.3 points compared to the baseline level
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
The proportion of achieving low disease activity as measured by CDAI(Phase I and Phase II)
The proportion of patients achieving a low disease activity score of ≤10 or ≤2.8 in the CDAI(Clinical Disease Activity Index) assessment
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
The proportion of participants with SDAI ≤ 11.0 or ≤ 3.3(Phase I and Phase II)
The proportion of participants with SDAI(Simplified Disease Activity Index) ≤ 11.0 or ≤ 3.3
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Assessment of morning stiffness changes and pain relative to baseline(Phase I and Phase II)
The assessment of morning stiffness changes (duration) and pain (using the Visual Analogue Scale [VAS]) relative to the baseline
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
The changes in RF and anti-CCP relative to the baseline(Phase I and Phase II)
The changes in rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies relative to the baseline
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Changes in D-dimer, hemoglobin, fibrinogen, and platelets relative to the baseline(Phase I and Phase II)
Changes in D-dimer, hemoglobin, fibrinogen, and platelets relative to the baseline;
Measured: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiankuan (Suzhou) Biotechnology Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856511
- Sponsor's protocol ID
- LJR001-RA-202601
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Proximod Tablets in Moderate-to-Severe Active Rheumatoid Arthritis Subjects With Inadequate Response or Intolerance to bDMARDs and/or tsDMARDs
- ClinicalTrials.gov ID
- NCT07856511
- Acronym / sponsor ID
- LJR001-RA-202601
- Conditions
- Rheumatoid Arthrits
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Jiankuan (Suzhou) Biotechnology Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 2 Oct 2026 (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.
This study is to evaluate the efficacy and safety of different doses of proximod in moderate-to-severe active rheumatoid arthritis subjects with inadequate response or intolerance to bDMARDs and/or tsDMARDs
Detailed description
This study is divided into two phases and planned to recruit 590 patients. Phase I: To evaluate the efficacy of different doses of proximod tablets compared to placebo in patients with moderate to severe active rheumatoid arthritis who have poor response or intolerance to bDMARDs and/or tsDMARDs. After the last administration and efficacy assessment (Week 16) of the core treatment period for the last participant, the primary endpoint analysis of Phase I will be conducted to determine the optimal dose for Phase II. Phase II: Using ACR20 as the primary efficacy indicator, to confirm that proximod tablets are more effective than placebo in patients with moderate to severe active rheumatoid arthritis who have poor response or intolerance to bDMARDs and/or tsDMARDs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase I: Placebo | Placebo comparator | Drug: PlaceboPlacebo for 16 weeks + Proximod tablets dose 1/dose 2 for 36 weeks |
| Phase I: Proximod dose 1 | Experimental | Drug: ProximodProximod tablets dose 1 for 52 weeks |
| Phase I: Proximod dose 2 | Experimental | Drug: ProximodProximod tablets dose 2 for 52 weeks |
| Phase II: Placebo | Placebo comparator | Drug: PlaceboPlacebo for 16 weeks + Proximod tablets dose 1 or dose 2 for 36 weeks |
| Phase II: Proximod | Experimental | Drug: ProximodProximod tablets dose 1 or dose 2 for 52 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- According to the 2010 classification criteria for rheumatoid arthritis (RA) of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR), the diagnosis is made for RA and the disease duration at the screening visit is at least 3 months.
- Moderate to severe RA defined by 6 or more tender joints, 6 or more swollen joints (68- or 66-joint count), and an ESR of 28 mm/h or greater or hsCRP > 1.2 × upper limit of laboratory normal range (ULN).
- Before the first administration, the participants had received MTX treatment for at least 3 consecutive months, with a stable dose for at least 4 weeks (oral or parenteral MTX [10-25 mg/week; or for those who were intolerant to the maximum dose of ≥10 mg/week, a dose of ≥7.5 mg/week could be used]).
- The participants had previously received at least one form of bDMARDs and/or tsDMARDs, but the treatment was either ineffective or they experienced intolerability. Ineffectiveness is defined as: After continuous treatment with the same bDMARD or tsDMARD for at least 12 weeks, there is still persistent or recurrent disease activity of rheumatoid arthritis, or the initial clinical improvement achieved during the treatment subsequently weakens or disappears, and the study investigator determines that the expected treatment goal has not been reached, thus requiring discontinuation or replacement of the drug. Intolerance is defined as: Those who have actually received treatment with a certain bDMARD or tsDMARD in the past and permanently discontinued the treatment due to recorded adverse events related to the drug, abnormal and clinically significant laboratory tests, or other toxicities, and the study investigator determines that continued use or re-use of the drug is not appropriate. Those who discontinue the treatment due to intolerance do not require a treatment duration of at least 12 weeks.
- Participants used a stable dose of oral/inhaled prednisone (≤ 10 mg/day) or an equivalent dose of glucocorticoids 4 weeks before the first administration of the study drug, and were expected to continue using the original stable dose during the trial; or they had stopped using oral/inhaled glucocorticoids ≥ 2 weeks before the first administration.
Key exclusion criteria (23 listed)
- Known or suspected allergies to the study drug or any component of the study drug.
- The ACR functional classification is level IV.
- Those who have been bedridden for a long time or are confined to a wheelchair for a long period of time.
- The participants plan to undergo joint surgery or major surgeries during the treatment period.
- During the screening, if the participant's forced expiratory volume in one second (FEV1) or forced vital capacity (FVC) was lower than 70% of the predicted value, and the FEV1/FVC ratio was less than 0.70;
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 |
|---|---|---|
| PlaceboThe placebo group will take drugs orally for 16 weeks, and then were randomly assigned to proximod dose 1 and proximod dose 2 for 36 weeks, in the meanwhile, proximod dose 1 group and proximod dose 2 group will continue taking drugs for the whole 52 weeks. | Drug | Phase I: Placebo |
| ProximodThe placebo group will take drugs orally for 16 weeks, and then were randomly assigned to proximod dose 1 and proximod dose 2 for 36 weeks, in the meanwhile, proximod dose 1 group and proximod dose 2 group will continue taking drugs for the whole 52 weeks. | Drug | Phase I: Proximod dose 1 |
| ProximodThe placebo group will take drugs orally for 16 weeks, and then were randomly assigned to proximod dose 1 and proximod dose 2 for 36 weeks, in the meanwhile, proximod dose 1 group and proximod dose 2 group will continue taking drugs for the whole 52 weeks. | Drug | Phase I: Proximod dose 2 |
| PlaceboThe placebo group will take drugs orally for 16 weeks, and then switch to proximod for 36 weeks, in the meanwhile, proximod group will continue taking drugs for the whole 52 weeks. | Drug | Phase II: Placebo |
| ProximodThe placebo group will take drugs orally for 16 weeks, and then switch to proximod for 36 weeks, in the meanwhile, proximod group will continue taking drugs for the whole 52 weeks. | Drug | Phase II: Proximod |
Primary outcome
ACR20 response rate at week 16(Phase I and Phase II)
Time frame: Week 16
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 16
16 secondary outcomes
ACR20 response rate(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, Week 20, Week 24, Week 32, week 40, week 48, week 52 and week 60
ACR50 response rate(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
ACR70 response rate(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Change from baseline in SDAI score(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Change from baseline in CDAI score(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Change from baseline in HAQ-DI score(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Change from baseline in DAS28-CRP(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Change from baseline in DAS28-ESR(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
DAS28-CRP<2.6 or≤3.2 proportion(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
DAS28-ESR<2.6 or≤3.2 proportion(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
The proportion of HAQ improvement(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
The proportion of achieving low disease activity as measured by CDAI(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
The proportion of participants with SDAI ≤ 11.0 or ≤ 3.3(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Assessment of morning stiffness changes and pain relative to baseline(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
The changes in RF and anti-CCP relative to the baseline(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
Changes in D-dimer, hemoglobin, fibrinogen, and platelets relative to the baseline(Phase I and Phase II)
Time frame: Week 2, Week 4, Week 8, week 12, week 16, Week 20, Week 24, Week 32, week 40, week 48, week 52, and week 60
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 2 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Proximod in people with Rheumatoid Arthrits, run by Jiankuan (Suzhou) Biotechnology Company Limited.
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 7 inclusion and 23 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ACR20 response rate at week 16(Phase I and Phase II) (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.