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

Rheumatoid Arthritis Clinical Trial

Official title:

Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis：A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05393050
• Other study ID #: 2022-001P6A01
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2022
• Est. completion date: June 2024

Study information

• Verified date: July 2022
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Quan Jiang, M.D
• Phone: +8613901081632
• Email: doctorjq[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Colquhounia Root Tablet
Colquhounia Root Tablet is a tripterygium preparation
• Methotrexate tablets
Methotrexate is a drug used to treat rheumatoid arthritis

Locations

Country	Name	City	State
China	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Quan Jiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of ACR20	Percentage of Participants With American College of Rheumatology 20% (ACR20)	week 24
Secondary	Percentage of ACR50	Percentage of Participants With American College of Rheumatology 50% (ACR50)	week 24
Secondary	Percentage of ACR70	Percentage of Participants With American College of Rheumatology 70% (ACR70)	week 24
Secondary	DAS28-ESR	28-joint disease activity score	week 24
Secondary	Chinese Patient-reported Activity Index with RA scale (PRO)	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.	week 24