Efficacy and Safety of Huo-Ba-Hua-Gen Tablet in Patients With Rheumatoid Arthritis

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate whether Huo-Ba-Hua-Gen Tablet combined with methotrexate (MTX) might be better than MTX alone for patients with active rheumatoid arthritis (RA).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Quan Jiang
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

1. Subject understood the whole process of the trial and signed the informed consent voluntarily.

2. Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.

3. Subjects aged between 45-70years who were the males without fertility requirements or menopausal women.

4. Subject has a DAS28 CRP disease activity score greater than 2.6 and less than 5.1.

5. Subject did not participate in any drug trials within 1 month before enrollment.

Exclusion Criteria:

1. Pregnant women, women planning to become pregnant or breastfeeding.

2. Severe systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, autoimmune liver disease.

3. Active liver disease or abnormal liver function, ALT and AST are more than 1.5 times the upper limit of normal.

4. Renal impairment, serum creatinine greater than the upper limit of normal.

5. Bone marrow hematopoietic dysfunction, peripheral blood leukocytes <3.0×109/L, or definite anemia (hemoglobin less than 80g/L), or platelets <80×109/L, or other blood system diseases.

6. Active gastric and duodenal ulcers.

7. Uncontrolled severe hypertension, metabolic diseases.

8. malignant tumors.

9. Acute and/or chronic infectious diseases.

10. Severe cardiac arrhythmia found on electrocardiogram.

11. Mental illness, history of alcoholism, drug or other substance abuse.

12. Diagnosed with other connective tissue disease.

13. Those who have used immunosuppressants, biological agents, Huo-Ba-Hua-Gen tablets or drugs containing Tripterygium wilfordii within 1 month before enrollment.

14. Those who have previously used methotrexate or preparations containing tripterygium wilfordii for 12 weeks or more ,but their condition is not under control.

15. Adverse reactions have occurred in the past using Huo-Ba-Hua-Gen tablets or drugs containing Tripterygium wilfordii.