Rheumatoid Arthritis Clinical Trial
Official title:
Safety and Efficacy of Optimal Methotrexate With Folic Acid in Patients With Rheumatoid Arthritis in Meizhou, Guangdong: a Randomized Case-control Study
This is an open, single-center, randomized,case controlled, prospective study. Previous
studies in China lacked data of efficacy and safety of optimal methotrexate (MTX) dose
with/without other anti-rheumatoid drugs (DMARDs) in the treatment of rheumatoid arthritis
(RA) .Meanwhile there was no study on the optimal folic acid dose in aspect of preventing
side effects of MTX. So we designed the experiment below.
The research planned to recruit 160 RA patients in Meizhou, Guangdong Province,China. The
volunteers had no relief with 10 mg of MTX per week with/without other DMARDs for at least 3
month. They were randomly divided into 1:1 groups. The experimental group would be treated
with original dMARDs ,incremental MTX( gradually increased to the optimal dose (0.3 mg/kg) in
the first 12 weeks）and folic acid (the dose adjusted as appropriate with range from 5 mg to
90 mg per week) . While the control group would be treated with original MTX（10mg per week)
and incremental original dMARDs( gradually increased to the maximum dose in the first 12
weeks). The two groups would keep the 12th week treatment last to the 36th week, and the
efficacy and safety indexes would be evaluated during the whole study.
The objective of the study was to determine the efficacy and safety of the optimal dose of
MTX in Chinese patients with rheumatoid arthritis, and to determine the efficacy and optimal
prevention dose of folic acid in Chinese RA patients. It might be helpful for Chinese
rheumatologists to use MTX accurately and efficiently to treat RA patients in clinical work.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
| Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
| Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
| Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
| Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
| Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
| Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
| Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
| Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
| Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
| Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
| Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
| Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
| Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
| Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
| Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
| Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
| Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |