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Optimal MTX Dose With Folic Acid Randomized Case-control Trial

NCT04066803 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2019-08-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

MTX

MTX group would be intervened by incremental MTX and folic acid，while the control group would be intervened by incremental original DMARDs they already used（including Leflunomide，Hydroxychloroquine,Sulfasalazine,Azathioprine,Tripterygium glycosides and Total glucosides of paeony)

DRUG

Folic Acid

MTX group would be intervened by folic acid，while the control group would be not intervened by folic acid

DRUG

DMARDs

including Leflunomide，Hydroxychloroquine,Sulfasalazine,Azathioprine,Tripterygium glycosides and Total glucosides of paeony

Sponsors & Collaborators

  • Shanghai Pharmaceuticals Holding Co., Ltd

    collaborator INDUSTRY

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yun Feng Pan, Master · the 3rd Hospital of Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-07-30
Completion
2020-07-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04066803 on ClinicalTrials.gov