The Clinical Study to Observe the Efficacy and Safety of Immunomodulators in Rheumatoid Arthritis Patients for 6 Months Treatment in China

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study includes naive patients and csDMARDs-IR RA patients, treated with different regimens such as Iguratimod combination of different csDMARDs, or csDMARD with TNF inhibitors for 24 weeks. The disease activity and drug response will be observed. The immune disorder and synovial function will be evaluated at the same time.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

∙ \-

• Patients with RA who meet ACR 1987 rheumatoid arthritis classification criteria or ACR/EULAR 2010 rheumatoid arthritis Classification Criteria and have knee dysfunction.

⁃ ACR 1987 rheumatoid arthritis classification criteria

∙ morning stiffness lasting at least 1 hour (≥6w)

‣ there are 3 or more joint areas swollen (≥6w)

‣ swelling of the wrist, metacarpophalangeal, and proximal phalangeal joint areas (≥6w)

‣ symmetrical arthrogryposis (≥6w)

‣ hand x-ray changes (at least osteoporosis and joint space narrowing)

‣ positive rheumatoid factor (titer \> 1:32) RA can be diagnosed by meeting 4 of the above 7 items

⁃ ACR/EULAR 2010 rheumatoid arthritis Classification Criteria

∙ Involved joints

∙ \- 1 large joint (0 points)

• 2-10 large joints (1 point)

• 1-3 small joints (with or without large joints) (2 points)

• more than 10 small joints (at least one small joint) (5 points)

‣ Serological indicators

⁃ RF and ACPA negative (0 points)

• RF and ACPA, at least one of which is low titer positive. (2 points)

• RF and ACPA with at least one high titer positive (3 points)

‣ Acute chronotropic reactants

⁃ Both CRP and ESR normal (0 points)

• Abnormal CRP or ESR (1 point)

‣ Duration of synovitis

⁃ \<6 weeks (0 points)

• ≥6 weeks (1 point)

‣ Patients with OA who meet the 1995 Classification Criteria for OA and have knee dysfunction 1995 Classification Criteria for Osteoarthritis of the Knee Clinical criteria

⁃ a. Knee pain most of the time in the last 1 month b. Bone rubbing sound c, morning stiffness ≤ 30 minutes d, age ≥ 38 years e, with bony enlargement Knee OA can be diagnosed if a+b+c+d or a+b+e is met

‣ Age-sex matched healthy volunteers who checked in our hospital.

‣ Age \> 18 years old;

‣ Voluntarily participate in this study and sign an informed consent form

Locations
Other Locations
China
Qilu Hospital
RECRUITING
Jinan
Contact Information
Primary
Qiang Shu, Dr.
shuqiang@sdu.edu.cn
0086-0531-82169654
Backup
Bingbing Ren
sdrenbingbing@163.com
0086-18765361979
Time Frame
Start Date: 2021-12-22
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 400
Treatments
Experimental: Methotrexate(MTX)+Iguratimod(IGU)
Drug: Iguratimod(IGU),25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.~Drug: Methotrexate(MTX),10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response.~For RA patients with naive or csDMARDs-IR
Experimental: Adalimumab+Methotrexate(MTX)
Drug: Adalimumab,40mg, iH,q2w, once two weeks (q2w) prescribed at the beginning and adjusted due to patient response.~Drug: Methotrexate(MTX),7-10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response.~For RA patients with csDMARDs-IR
Experimental: Iguratimod(IGU)+Leflunomide(LEF)+Hydroxychloroquine(HCQ)
Drug: Iguratimod(IGU),25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.~Drug: Leflunomide(LEF),20mg, po, quaque day (qd) prescribed at the beginning and adjusted due to patient response.~Drug: Hydroxychloroquine(HCQ),200mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.~For RA patients with csDMARDs-IR
Related Therapeutic Areas
Sponsors
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov