Methotrexate Adverse ReactionPhase 4SCMTXRANCT07094880
Subcuteous Methotrexate in Rheumatoid Arthritis
A Phase 4 study testing Tab. Methotrexate 25mg/week and Inj. Methotrexate 25mg/week in people with Methotrexate Adverse Reaction and Advantage of Using Subcutaneous Route for Methotrexate, run by Bangladesh Medical University.
Trial summary
Methotrexate use is important for the treatment of Rheumatoid arthritis. Some patients can not tolerate oral methotrexate. So subcutaneous may help to overcome it. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Methotrexate Adverse Reaction, Advantage of Using Subcutaneous Route for Methotrexate
- What is being tested?
- Tab. Methotrexate 25mg/week and Inj. Methotrexate 25mg/week
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 1 Jun 2016
- 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
- Patient must fulfill the ACR 1987 revised criteria
- The disease should be active
- Age 18-70 years
Who cannot join
- Presence of other rheumatologic disorder
- Pregnancy, lactating mother and women with child bearing potential failing to confirm adequate contraception
About this study
Official title: Study on the Use of Subcuteous Use of Methotrexate in Patients With Active Rheumatoid Arthritis
Methotrexate use is important for the treatment of Rheumatoid arthritis. Some patients can not tolerate oral methotrexate. So subcutaneous may help to overcome it.
Read the detailed description
Objective: To see the efficacy and safety of subcutaneous (SC) methotrexate (MTX) in patients suffering from active rheumatoid arthritis (RA). Methods: This was an open labeled randomized clinical trial. Total 90 patients were enrolled from out-patient and in-patients department of medicine (Rheumatology wing) Bangabandhu Sheikh Mujib Medical University. This study was done in two phases. In phase 1, after enrollment 10 mg MTX was given to all patients. After 4 weeks, the dose of MTX was increased by 5 mg. All patients were followed up at 8 weeks from enrollment for outcome measures and tolerability. In phase 2, patients who are intolerant to oral MTX will received 20 mg MTX subcutaneously (n=40). After 8 weeks the dose of MTX was increased by 5 mg. So, 25 mg MTX was given and after another 8 weeks final follow up was given both for clinical and laboratory outcome measures.
- Being tested
- Tab. Methotrexate 25mg/week, Inj. Methotrexate 25mg/week
- Keywords
- Oral Methotrexate, Subcutaneous Methotrexate, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tab. Methotrexate 25mg/weekDrug
Tab. Methotrexate will be given orally in one arm at a dose of 25 mg/week
Inj. Methotrexate 25mg/weekDrug
Inj. Methotrexate 25 mg/week will be given subcutaneously in another arm
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Oral Methotrexate 25 mg will be given weekly Receives: Drug: Tab. Methotrexate 25mg/week |
| Group B | Active comparator | Subcutaneous methotrexate will be given 25mg/week Receives: Drug: Inj. Methotrexate 25mg/week |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology 20
20% reduction in disease activity
Measured: "From enrollment to the end of treatment at 16 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Jun 2015
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methotrexate Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Md. Masudul Hassan, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094880
- Sponsor's protocol ID
- 712/2013
- Acronym
- SCMTXRA
- Status last verified
- Jul 2025
- First submitted
- 29 May 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Use of Subcuteous Use of Methotrexate in Patients With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07094880
- Acronym / sponsor ID
- SCMTXRA / 712/2013
- Keywords
- Oral Methotrexate, Subcutaneous Methotrexate, Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Methotrexate use is important for the treatment of Rheumatoid arthritis. Some patients can not tolerate oral methotrexate. So subcutaneous may help to overcome it.
Detailed description
Objective: To see the efficacy and safety of subcutaneous (SC) methotrexate (MTX) in patients suffering from active rheumatoid arthritis (RA). Methods: This was an open labeled randomized clinical trial. Total 90 patients were enrolled from out-patient and in-patients department of medicine (Rheumatology wing) Bangabandhu Sheikh Mujib Medical University. This study was done in two phases. In phase 1, after enrollment 10 mg MTX was given to all patients. After 4 weeks, the dose of MTX was increased by 5 mg. All patients were followed up at 8 weeks from enrollment for outcome measures and tolerability. In phase 2, patients who are intolerant to oral MTX will received 20 mg MTX subcutaneously (n=40). After 8 weeks the dose of MTX was increased by 5 mg. So, 25 mg MTX was given and after another 8 weeks final follow up was given both for clinical and laboratory outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Tab. Methotrexate 25mg/weekOral Methotrexate 25 mg will be given weekly |
| Group B | Active comparator | Drug: Inj. Methotrexate 25mg/weekSubcutaneous methotrexate will be given 25mg/week |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient must fulfill the ACR 1987 revised criteria
- The disease should be active
- Age 18-70 years
Key exclusion criteria (2 listed)
- Presence of other rheumatologic disorder
- Pregnancy, lactating mother and women with child bearing potential failing to confirm adequate contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tab. Methotrexate 25mg/weekTab. Methotrexate will be given orally in one arm at a dose of 25 mg/week | Drug | Group A |
| Inj. Methotrexate 25mg/weekInj. Methotrexate 25 mg/week will be given subcutaneously in another arm | Drug | Group B |
Primary outcome
American College of Rheumatology 20
Time frame: "From enrollment to the end of treatment at 16 weeks"
20% reduction in disease activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Methotrexate Adverse Reaction
Not yet recruitingPhase 4
The Possible Efficacy and Protective Effect of Empagliflozin in Rheumatoid Arthritis Patients Treated with Methotrexate
Rheumatoid Arthritis (RA), Methotrexate Induced Nephrotoxicity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tab. Methotrexate 25mg/week and Inj. Methotrexate 25mg/week in people with Methotrexate Adverse Reaction and Advantage of Using Subcutaneous Route for Methotrexate, run by Bangladesh Medical University.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American College of Rheumatology 20 (time frame: "From enrollment to the end of treatment at 16 weeks"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2025.