Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis

Phase 4

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Colquhounia Root Tablet; Drug: Methotrexate tablets

• Registration Number: NCT05393050
• Lead Sponsor: Quan Jiang

Brief 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 Colquhounia Root Tablet combined with methotrexate (MTX) might be better than MTX alone for patients with active rheumatoid arthritis (RA).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-26
• Status Verified: 2022-07
• Study Start: 2022-07
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-08
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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, Colquhounia Root Tablet 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 Colquhounia Root Tablet or drugs containing Tripterygium wilfordii.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colquhounia Root Tablet plus methotrexate (MTX)	Methotrexate tablets	Colquhounia Root Tablet 0.9g tid and methotrexate (MTX) 10 mg oncea week for the first 12 weeks，Colquhounia Root Tablet 0.54g tid and methotrexate (MTX) 10 mg once a week for the after 12 weeks.
placedo of Colquhounia Root Tablet plus methotrexate (MTX)	Methotrexate tablets	placedo of Colquhounia Root Tablet 0.9g tid and methotrexate (MTX) 10 mg oncea week for the first 12 weeks，placedo of Colquhounia Root Tablet 0.54g tid and methotrexate (MTX) 10 mg once a week for the after 12 weeks.
Colquhounia Root Tablet plus methotrexate (MTX)	Colquhounia Root Tablet	Colquhounia Root Tablet 0.9g tid and methotrexate (MTX) 10 mg oncea week for the first 12 weeks，Colquhounia Root Tablet 0.54g tid and methotrexate (MTX) 10 mg once a week for the after 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of ACR20	week 24	Percentage of Participants With American College of Rheumatology 20% (ACR20)

Secondary Outcome Measures

Name	Time	Method
Percentage of ACR70	week 24	Percentage of Participants With American College of Rheumatology 70% (ACR70)
Percentage of ACR50	week 24	Percentage of Participants With American College of Rheumatology 50% (ACR50)
DAS28-ESR	week 24	28-joint disease activity score
Chinese Patient-reported Activity Index with RA scale (PRO)	week 24	Patient-Reported Outcomes Scale,The self-rating scale consists of 12 items,Each item was rated 0, 1, 2 and 3 on the scale of asymptomatic to aggravating symptoms, respectively.

Trial Locations

Locations (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China