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Rheumatoid ArthritisPhase 4MTXFARCTNCT04066803

Optimal MTX Dose With Folic Acid Randomized Case-control Trial

A Phase 4 study testing MTX, Folic Acid and DMARDs in people with Rheumatoid Arthritis, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
MTX, Folic Acid and DMARDs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
1 Aug 2018to 30 Jul 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • According to the revised 1987 American Academy of Rheumatology (ACR) RA classification criteria, subjects must be diagnosed as rheumatoid arthritis ≥6 months.
  • MTX was given 10 mg/week（not the maximum dose of MTX (calculated as 0.3 mg/kg)) for ≥3 months before admission.
  • 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;
  • The age of the subjects ranged from 18 to 70 years.
  • 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.
  • Women of childbearing age should agree to take effective contraceptive measures during the trial period;
  • The urinary pregnancy test of women of childbearing age was negative at screening time.
  • Understand the steps and contents of the experiment and sign the informed consent to participate in the experiment.

Who cannot join

  • Those who underwent major surgery (including joint surgery) within 8 weeks before screening or who planned major surgery within 6 months after random selection;
  • 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.
  • Inflammatory arthritis (such as gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) .
  • Intra-articular injection or other injection of corticosteroids within 4 weeks before baseline;
  • Those who had been vaccinated with live/inactivated vaccine within 4 weeks before baseline;
  • Three months before admission, the following drugs were used: cyclophosphamide, biological agents and folic acid.
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  • DMARDs dose reached maximum dosage in 3 months before admission， or DMARDs≥3 were used in 3 months before admission
  • 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;
  • 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;
  • Subjects with a history of malignant tumors, including solid tumors and hematological malignancies (except excised or cured skin basal cell carcinomas);
  • Pregnant or lactating women (breastfeeding);
  • Subjects with neuropathy and other painful diseases may interfere with pain assessment.
  • Serum creatinine > 1.5 mg/dl (equivalent to 133 umol/L);
  • 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).
  • Platelet count < 100 x 10^9/L, or white blood cells < 3 x 10^9/L;

Trial locations and contacts

1 site in 1 country.

Dong Fang Lin, Doctor contact

8618688493601

619849304@qq.com

Yan Li Zhang, Doctor contact

8613430278467

zhangyanli04386@163.com

China1 site, 1 recruiting

  • the 3rd Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510630

    Dong Fang Lin, Doctor, 8618688493601, 619849304@qq.com

    Yan Li Zhang, Doctor, 8613430278467, zhangyanli04386@163.com

    Recruiting

Other trials in China

About this study

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.

Being tested
MTX, Folic Acid, DMARDs
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MTXDrug

    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)

  • Folic AcidDrug

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

  • DMARDsDrug

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

Study groups in NCT04066803
Study groupRoleWhat they receive
MTX group with folic acidExperimentalthe group with optimal MTX dose (gradually increased from 0 to 12weeks，appropriate folic acid，and stable original other DMARDs
Receives: Drug: MTX; Drug: Folic Acid; Drug: DMARDs
control group without folic acidActive comparatorthe group with stable MTX 10mg/w dose and maximum DMARDs doses（graduallly increased from 0 to 12 weeks）without folic acid
Receives: Drug: MTX; Drug: DMARDs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The response rate of ACR20 at the 36th weeks

    Measured: at the 36th weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2019
  2. Study start1 Aug 2018
  3. Primary completion30 Jul 2020 (estimated)
  4. Study completion30 Jul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04066803
Sponsor's protocol ID
QHJH201805
Acronym
MTXFARCT
Status last verified
Aug 2019
First submitted
11 Dec 2018
Last updated
26 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share.

Publications

  • Gaujoux-Viala C, Rincheval N, Dougados M, Combe B, Fautrel B. Optimal methotrexate dose is associated with better clinical outcomes than non-optimal dose in daily practice: results from the ESPOIR early arthritis cohort. Ann Rheum Dis. 2017 Dec;76(12):2054-2060. doi: 10.1136/annrheumdis-2017-211268. Epub 2017 Sep 2.

    PubMed 28866645

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MTX, Folic Acid and DMARDs in people with Rheumatoid Arthritis, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dong Fang Lin, Doctor (8618688493601, 619849304@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The response rate of ACR20 at the 36th weeks (time frame: at the 36th weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04066803, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.

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