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

NCT05393050 | Unknown Phase 4

• 1 other identifier: 2022-001P6A01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Colquhounia Root Tablet; Methotrexate; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Percentage of ACR20

  Percentage of Participants With American College of Rheumatology 20% (ACR20)

  week 24

Secondary Outcomes (4)

• Percentage of ACR50

  week 24

• Percentage of ACR70

  week 24

• DAS28-ESR

  week 24

• Chinese Patient-reported Activity Index with RA scale (PRO)

  week 24

Study Arms (2)

Colquhounia Root Tablet plus methotrexate (MTX)

ACTIVE COMPARATOR

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.

Drug: Colquhounia Root Tablet; Drug: Methotrexate tablets

placedo of Colquhounia Root Tablet plus methotrexate (MTX)

PLACEBO COMPARATOR

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.

Drug: Methotrexate tablets

Interventions

Colquhounia Root Tablet DRUG

Colquhounia Root Tablet is a tripterygium preparation

Colquhounia Root Tablet plus methotrexate (MTX)

Methotrexate tablets DRUG

Methotrexate is a drug used to treat rheumatoid arthritis

Colquhounia Root Tablet plus methotrexate (MTX); placedo of Colquhounia Root Tablet plus methotrexate (MTX)

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject understood the whole process of the trial and signed the informed consent voluntarily.
• Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.
• Subjects aged between 45-70years who were the males without fertility requirements or menopausal women.
• Subject has a DAS28 CRP disease activity score greater than 2.6 and less than 5.1.
• Subject did not participate in any drug trials within 1 month before enrollment.

You may not qualify if:

• Pregnant women, women planning to become pregnant or breastfeeding.
• Severe systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, autoimmune liver disease.
• Active liver disease or abnormal liver function, ALT and AST are more than 1.5 times the upper limit of normal.
• Renal impairment, serum creatinine greater than the upper limit of normal.
• 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.
• Active gastric and duodenal ulcers.
• Uncontrolled severe hypertension, metabolic diseases.
• malignant tumors.
• Acute and/or chronic infectious diseases.
• Severe cardiac arrhythmia found on electrocardiogram.
• Mental illness, history of alcoholism, drug or other substance abuse.
• Diagnosed with other connective tissue disease.
• Those who have used immunosuppressants, biological agents, Colquhounia Root Tablet or drugs containing Tripterygium wilfordii within 1 month before enrollment.
• Those who have previously used methotrexate or preparations containing tripterygium wilfordii for 12 weeks or more ,but their condition is not under control.
• Adverse reactions have occurred in the past using Colquhounia Root Tablet or drugs containing Tripterygium wilfordii.

Sponsors & Collaborators

• Quan Jiang: lead

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100052, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Quan Jiang, M.D

CONTACT

+8613901081632; doctorjq@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)