Rheumatoid Arthritis(RA) Clinical Trial
Official title:
A Prospective Cohort Study to Observe the Difference of Efficacy Between Infliximab With Methotrexate and Classic DMARDs in the Severe Rheumatoid Arthritis Patients With Poor Prognosis
A prospective, multi-centric, cohort study to observe the efficacy difference between intensive classic DMARDs and Infliximab(IFX) with methotrexate(MTX) treatment in sever rheumatoid arthritis(RA) 28 joints disease activity score>5.1(DAS28>5.1) patients with poor prognostic factors.Primary objective is compare the difference of clinical remission rate between classic DMARDs and Infliximab with MTX treatment in severe RA patients with poor prognostic factors at week 30.
Primary objective is compare the difference of clinical remission rate between classic
conventional disease-modifying antirheumatic drugs(DMARDs) and Infliximab with
methotrexate(MTX) treatment in severe RA patients with poor prognostic factors at week 30.
Secondary objectives are compare the differences of laboratory measurements, clinical
remission rate, function score and imageological evaluation between classic DMARDs and
Infliximab with MTX treatment in severe RA patients with poor prognostic factors at week 14,
30, 54 and 102.
Infliximab arm：Infliximab with MTX treatment: Infliximab 3mg/kg at week 0, 2, 6 and then
once every 8 weeks, MTX>7.5mg per week. To observe the results at week 14, 30, 54 and 102
after 6 times IFX treatment. It recommended that continue to receiving IFX treatment after
remission for a period of time in good economic condition patients while receiving MTX with
hydroxychloroquine(HCQ) or leflunomide(LEF) in poor economic condition patients.
Classic DMARDs treatment arm： Classic DMARDs treatment combination of 2 or 3 drugs, 2-drugs
combination is MTX with LEF or Thunder God Vine, 3-drugs combination is MTX with HCQ and LEF
or Thunder God Vine for total 30 weeks.
Effective dose: MTX: 10-15mg per week; LEF: 20mg per day; HCQ: 200-400 mg per day; Thunder
God Vine: 40-60 mg per day; It recommended that the maintain regimen is MTX with HCQ or LEF
after remission for a period of time.
Study is divided into three stages First stage: day -7 to 0
1. Sign informed consent;
2. Examine and verify the inclusion and exclusion criteria;
3. Collect the data of demographic characteristics, history of present illness, signs and
symptoms, history of previous illness and concomitant medicine, personal history,
allergic history, injury and surgery history;
4. Data of laboratory examinations: Rheumatoid Factor(RF),anti citrullinated protein
antibodies(ACPA) ;
5. Safety data: vital signs, blood routine examination, biochemical test;
6. Efficacy data: Erythrocyte Sedimentation Rate(ESR), C Reactive Protein(CRP), 28 joints
disease activity score(DAS28 score), Simplified disease activity index(SDAI) score,
American College Of Rheumatology(ACR)/European League Against Rheumatism(EULAR)
remission ,Sharp van der Heijde scoring(SHARP) score, Magnetic Resonance Imaging(MRI)
score, Health Assessment Questionnaire(HAQ) score;
Second stage: week 0 to week 30, follow-up duration I The subjects are randomized assigned
to achieve experimental or control treatment for 30 weeks and follow up at week 2, 6, 14, 22
and 30.
1. The follow up items are same at week 2 and week 22: signs and symptoms, ESR, CRP;
2. The follow up items at week 6: signs and symptoms, blood routine examinations,
biochemical test, ESR, CRP;
3. The follow up items at week 14: signs and symptoms, ESR, CRP, DAS28 score, SDAI score,
ACR/EULAR remission, SHARP score, MRI score, HAQ score;
4. The follow up items at week 30: signs and symptoms, RF, ACPA, blood routine
examinations, biochemical test, ESR, CRP, DAS28 score, SDAI score, ACR/EULAR remission,
SHARP score, MRI score, HAQ score.
Third stage: Week 30 to 102, follow-up duration II After 30 weeks treatment the subjects are
into 72 weeks follow-up duration, the follow up will be conducted at week 38, 46, 54 and
102.
1. The follow up items are same at week 38 and 46: signs and symptoms, ESR, CRP;
2. The follow up items: signs and symptoms, blood routine examinations, biochemical test,
ESR, CRP, DAS28 score, ACR/EULAR remission, SHARP score, MRI score, HAQ score;
3. The follow up items at week 102: signs and symptoms, RF, ACPA, blood routine
examinations, biochemical test, ESR, CRP, DAS28 score, SDAI score, ACR/EULAR remission,
SHARP score, MRI score, HAQ score.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04312815 -
A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX
|
Phase 3 |