Rheumatoid ArthritisPhase 4NCT04464642
Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis
A Phase 4 study testing Methotrexate and Tofacitinib in people with Rheumatoid Arthritis, run by Dr. Mohammad Mamun Khan at 1 site in Bangladesh.
Trial summary
It is a randomized controlled study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Methotrexate and Tofacitinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBangladesh
- Study dates
- 10 Jul 2019to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- systemic infection
- hemoglobin less than 9 mg/dl
- WBC <4000, neutrophil <1000, platelet <100000/mm
- live vaccine within 3 months
- GFR < 50 ml/min
- ALT > 2 times ULN
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
It is a randomized controlled study
Read the detailed description
Randomization controlled study on Rheumatoid arthritis patients whos disease activity is high, controlled subjects will be given methotrexate and study subjects will get tofacitinib
- Conditions
- Rheumatoid Arthritis
- Being tested
- Methotrexate, Tofacitinib
- Keywords
- rheumatoid arthritis tofacitinib methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called injection trexonate
Methotrexate 25 mg subcutaneous is given in group A
TofacitinibDrug
Also called tofacit
tofacitinib 10 mg given in group B
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | group "A" is a control arm who will get conventional drug (methotrexate). 25 mg subcutaneous weekly . at 3 months if DAS-28 not fall by at least 1.2, drug is to be changed and regarded as therapy failure. if at least 1.2 improvement of DAS-28 occur,then therapy is continued for 6 monyhs Receives: Drug: Methotrexate |
| group B | Experimental | group "B" will get tofacitinib 10 mg weekly. if DAS-28 not improved at least 1.2 at 3 months, it is regarded as therapy failure. if improved at least 1.2, then therapy continued for 6 months Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS-28 CRP at 6 month
disease activity score in 28 joints has to measured at 6 months
Measured: 6 months
Secondary outcomes (2)
SDAI at 6 months
simplified disease activity index at 6 months
Measured: 6 months
HAQ-DI at 6 months
health assesment by HAQ-DI at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start10 Jul 2019
- Primary completionAug 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- Model description
- open label Randomization controlled clinical study
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Mohammad Mamun Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Mohammad Mamun Khan, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Mohammad M Khan, MBBS, Principal investigator, Resident doctor, BSMMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464642
- Sponsor's protocol ID
- BSMMU /2019/5499
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan MM, Ahmed S, Hasan Sajib MK, Morshed AA, Mahbub-Uz-Zaman K, Haq SA. Tofacitinib versus methotrexate as the first-line disease-modifying antirheumatic drugs in the treatment of rheumatoid arthritis: An open-label randomized controlled trial. Int J Rheum Dis. 2023 Sep;26(9):1729-1736. doi: 10.1111/1756-185X.14801. Epub 2023 Jun 28.
PubMed 37377385
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04464642
- Acronym / sponsor ID
- BSMMU /2019/5499
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis tofacitinib methotrexate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Dr. Mohammad Mamun KhanUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 9 Jul 2020 (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.
It is a randomized controlled study
Detailed description
Randomization controlled study on Rheumatoid arthritis patients whos disease activity is high, controlled subjects will be given methotrexate and study subjects will get tofacitinib
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label Randomization controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: Methotrexategroup "A" is a control arm who will get conventional drug (methotrexate). 25 mg subcutaneous weekly . at 3 months if DAS-28 not fall by at least 1.2, drug is to be changed and regarded as therapy failure. if at least 1.2 improvement of DAS-28 occur,then therapy is continued for 6 monyhs |
| group B | Experimental | Drug: Tofacitinibgroup "B" will get tofacitinib 10 mg weekly. if DAS-28 not improved at least 1.2 at 3 months, it is regarded as therapy failure. if improved at least 1.2, then therapy continued for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- systemic infection
- hemoglobin less than 9 mg/dl
- WBC <4000, neutrophil <1000, platelet <100000/mm
- live vaccine within 3 months
- GFR < 50 ml/min
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 |
|---|---|---|
| MethotrexateAlso: injection trexonateMethotrexate 25 mg subcutaneous is given in group A | Drug | group A |
| TofacitinibAlso: tofacittofacitinib 10 mg given in group B | Drug | group B |
Primary outcome
DAS-28 CRP at 6 month
Time frame: 6 months
disease activity score in 28 joints has to measured at 6 months
2 secondary outcomes
SDAI at 6 months
Time frame: 6 months
HAQ-DI at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Derived from this study: PubMed 37377385Khan MM, Ahmed S, Hasan Sajib MK, Morshed AA, Mahbub-Uz-Zaman K, Haq SA. Tofacitinib versus methotrexate as the first-line disease-modifying antirheumatic drugs in the treatment of rheumatoid arthritis: An open-label randomized controlled trial. Int J Rheum Dis. 2023 Sep;26(9):1729-1736. doi: 10.1111/1756-185X.14801. Epub 2023 Jun 28.
- Individual participant dataSharing planned: No
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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.
Mohammad M Khan, MBBS principal investigator
Resident doctor, BSMMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methotrexate and Tofacitinib in people with Rheumatoid Arthritis, run by Dr. Mohammad Mamun Khan at 1 site in Bangladesh.
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 0 inclusion and 7 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 9 Jul 2020. 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 Bangladesh. 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?
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?
DAS-28 CRP at 6 month (time frame: 6 months). 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 NCT04464642, 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 9 Jul 2020.