Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis (TRIFRA)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 3; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Methotrexate; Drug: Tripterygium wilfordii Hook F

Study type: Interventional

Funder types: Other

Identifiers

NCT01613079

TRIFRA

Details and patient eligibility

About

Evaluation of oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of RA patients with clinical efficacy and safety.Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.

Enrollment: 201 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-65 years with informed consent
• Diagnosed with rheumatoid arthritis as determined by meeting the 2010 ACR/EULAR classification criteria and has had rheumatoid arthritis for at least 6 weeks
• Swollen joint (SJC)≥3 and tender joint count(TJC)≥5
• ESR >28 mm/hr or C-reactive protein > 20 mg/L

Exclusion criteria

• Pregnant, lactating or further fertility requirements
• Previous treated with methotrexate or biologic DMARD.
• Active or chronic infection, including HIV, HCV, HBV, tuberculosis
• Patient with cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

201 participants in 3 patient groups, including a placebo group

Methotrexate

Placebo Comparator group

Description:

Patients were treated with methotrexate alone.

Treatment:

Drug: Methotrexate

T2

Experimental group

Description:

Patients were treated with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).

Treatment:

Drug: Tripterygium wilfordii Hook F

MTX+T2

Experimental group

Description:

The patients were treated with methotrexate and T2.

Treatment:

Drug: Methotrexate

Drug: Tripterygium wilfordii Hook F