Optimal MTX Dose With Folic Acid Randomized Case-control Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04066803
• Date of registration: 11/12/2018
• Prospective Registration: No
• Primary sponsor: Sun Yat-sen University
• Public title: Optimal MTX Dose With Folic Acid Randomized Case-control Trial MTXFARCT
• Scientific title: Safety and Efficacy of Optimal Methotrexate With Folic Acid in Patients With Rheumatoid Arthritis in Meizhou, Guangdong: a Randomized Case-control Study
• Date of first enrolment: August 1, 2018
• Target sample size: 160
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04066803
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

China

Contacts

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

• Name: Dong Fang Lin, Doctor

• Name: Dong Fang Lin, Doctor

Key inclusion & exclusion criteria

Inclusion Criteria:

1. According to the revised 1987 American Academy of Rheumatology (ACR) RA classification
criteria, subjects must be diagnosed as rheumatoid arthritis =6 months.

2. MTX was given 10 mg/week(not the maximum dose of MTX (calculated as 0.3 mg/kg)) for =3
months before admission.

3. At the screening and baseline phases, the number of swollen joints (SJC) should be =1
(counting 66 joints), and the number of tender joints (TJC) should be = 1 (counting 66
joints); the ESR should be =20 mm/h, and/or the CRP should be = 10 mg/l;

4. The age of the subjects ranged from 18 to 70 years.

5. The following RA drugs can be used in combination within 3 months before admission;
oral glucocorticoid (prednisone =10 mg/d or its equivalent), non-steroidal
anti-inflammatory drugs (= the maximum recommended dose), leflunomide,
hydroxychloroquine, sulfasalazine, total paeoniflorin, Tripterygium glycoside,
azathioprine, and MTX. The stable dose of DMARDs should be at least 4 weeks before
baseline, and the combined dose of DMARDs beside MTX could not reach the full dose.

6. Women of childbearing age should agree to take effective contraceptive measures during
the trial period;

7. The urinary pregnancy test of women of childbearing age was negative at screening
time.

8. Understand the steps and contents of the experiment and sign the informed consent to
participate in the experiment.

Exclusion Criteria:

1. Those who underwent major surgery (including joint surgery) within 8 weeks before
screening or who planned major surgery within 6 months after random selection;

2. Patients with autoimmune diseases except RA include SLE, MCTD, scleroderma and
polymyositis. But subjects with RA and secondary Sjogren syndrome were allowed to
participate in the trial.

3. Inflammatory arthritis (such as gout, reactive arthritis, psoriatic arthritis,
seronegative spondyloarthropathy, Lyme disease) .

4. Intra-articular injection or other injection of corticosteroids within 4 weeks before
baseline;

5. Those who had been vaccinated with live/inactivated vaccine within 4 weeks before
baseline;

6. Three months before admission, the following drugs were used: cyclophosphamide,
biological agents and folic acid.

7. DMARDs dose reached maximum dosage in 3 months before admission, or DMARDs=3 were used
in 3 months before admission

8. Subjects with severe uncontrolled diseases including cardiovascular disease, nervous
system disease, pulmonary disease (including obstructive pulmonary disease and
interstitial lung disease), nephropathy, liver disease, endocrine disease (including
uncontrolled diabetes mellitus) and gastrointestinal diseases;

9. known history of active or recurrent bacterial, viral, fungal, Mycobacterium or other
infections (including, but not limited to, tuberculosis and atypical mycobacterium
diseases, chest X-rays showing granulomatous diseases, hepatitis B and C, HIV
infection, herpes zoster, but excluding Onychomycosis) ,any infection requiring
hospitalization and intravenous antibiotic therapy within 4 weeks before screening ,or
oral antibiotic therapy within 2 weeks before screening; active hepatitis B refers to
HBsAg-positive patients without antiviral drugs and HBV-DNA > 10^4; active hepatitis C
refers to anti-HCV-positive patients without antiviral drugs and HCV-RNA > 10^4;

10. Subjects with a history of malignant tumors, including solid tumors and hematological
malignancies (except excised or cured skin basal cell carcinomas);

11. Pregnant or lactating women (breastfeeding);

12. Subjects with neuropathy and other painful diseases may interfere with pain
assessment.

13. Serum creatinine > 1.5 mg/dl (equivalent to 133 umol/L);

14. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times of the
upper limit of normal value (if ALT or AST is greater than 2 times of the upper limit
of normal value for the first time, it should be sampled again during the screening
period), or total bilirubin is greater than the upper limit of normal value (if total
bilirubin is greater than the upper limit of normal value for the first time at the
screening, sampling should be done again during the selection period).

15. Platelet count < 100 x 10^9/L, or white blood cells < 3 x 10^9/L;



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Folic Acid

Drug: DMARDs

Drug: MTX

Primary Outcome(s)

The response rate of ACR20 at the 36th weeks [Time Frame: at the 36th weeks]

Secondary ID(s)

QHJH201805

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shanghai Pharmaceuticals Holding Co., Ltd