Rheumatoid ArthritisPhase 4NCT05827497
Baricitinib, Methotrexate as Monotherapy or Combination in the Treatment of Rheumatoid Arthritis - an Open Label Randomized Clinical Trial
A Phase 4 study testing Baricitinib 2 MG and Methotrexate 25mg in people with Rheumatoid Arthritis, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
The goal of this open-label randomized clinical trial is to assess the efficacy of baricitinib 2 mg in comparison to methotrexate 25 mg as monotherapy followed by baricitinib 4 mg in comparison to methotrexate 10 mg and baricitinib 2 mg combination in patients with rheumatoid arthritis with moderate to severe disease… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Baricitinib 2 MG and Methotrexate 25mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Apr 2023to 31 Mar 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Patients more than 18 years of age 2. Patients fulfill the ACR/EULAR 2010 classification criteria for Rheumatoid arthritis 3. Patients with DAS 28 ESR> 3.2
Who cannot join
- 1. Recent or concurrent infection including active tuberculosis 2. Haemoglobin (Hb) < 9 gm/dl 3. Total WBC count < 4000 / µL 4. Neutrophil count < 1200 / µL 5. Lymphocyte count < 750 / µL 6. AST/ALT > three times the upper limit of normal 7. Estimated glomerular filtration rate < 60 ml/minute/1.73 m2 8. Co-morbid illness- e.g., Malignancy 9 . Pregnant or breast feeding woman
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
Dr. Md. Abu Shahin
Dhaka
Dr. Md Abu Shahin, FCPS, MD, +8801711313416, abushahinrh@gmail.com
About this study
The goal of this open-label randomized clinical trial is to assess the efficacy of baricitinib 2 mg in comparison to methotrexate 25 mg as monotherapy followed by baricitinib 4 mg in comparison to methotrexate 10 mg and baricitinib 2 mg combination in patients with rheumatoid arthritis with moderate to severe disease activity. The main question it aims to answer:
- Is there any difference in the efficacy of baricitinib as monotherapy in comparison to methotrexate monotherapy or methotrexate-baricitinib combination in the treatment of rheumatoid arthritis
Read the detailed description
This open-label randomized clinical trial will be conducted in the department of rheumatology, BSMMU. The rheumatoid arthritis patients with moderate to high disease activity at baseline, disease activity score (DAS28ESR>3.2) will be considered as primary entry criteria for this study. Consecutive sampling method will be applied. The study will be done in 2 phases, duration of each phase 24 weeks. Considering inclusion and exclusion criteria, total 132 patients are randomized into group A and group B following block randomization. Each group will be consisting of 66 patients. In phase 1 Group A will be put on baricitinib 2 mg once daily and Group B will be put on methotrexate 25 mg weekly. The patients who fail to achieve remission or low disease activity by 24 weeks eligible for entry into phase 2 where group A will be put on baricitinib 4 mg and group B will be put on baricitinib 2 mg in combination with methotrexate 10 mg. Follow-up will be done at the 4th, 12th and 24th week in phase 1 and 28th, 36th and 48th week in phase 2. Response to treatment will be evaluated by DAS 28 ESR. At the end of 24th week endpoint for efficacy will be assessed at by DAS 28ESR. Adverse effects will be assessed by history, physical examinations and investigations.
Results will be compared among two groups with a 95% confidence interval and a p-value of < 0.05. The degrees of statistical significance between groups will be analyzed by unpaired t-test and/or Mann-Whitney U test. Qualitative data in between groups will be analyzed by the chi-square test. Probabilities of associations will be assessed by calculating Spearman´s rank correlation coefficient
- Conditions
- Rheumatoid Arthritis
- Being tested
- Baricitinib 2 MG, Methotrexate 25mg
- Keywords
- baricitinib, 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.
Baricitinib 2 MGDrug
Also called Baricitinib 2mg
baricitinib 2 mg once daily
Methotrexate 25mgDrug
25mg daily
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | baricitinib 2 mg once daily Receives: Drug: Baricitinib 2 MG |
| Group B | Active comparator | methotrexate on 25 mg weekly Receives: Drug: Methotrexate 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS 28 ESR
Following parameters are used to evaluate DAS28- Tender joint count Swollen joint count Patient global assessment (vas in cm) ESR/CRP
Measured: 24 weeks
Secondary outcomes (2)
Clinical disease activity index (CDAI)
Tender joint count Swollen joint count Patient global assessment (vas in cm) Physician global assessment (vas in cm)
Measured: 24 weeks
Health assessment questionnaire disability index (HAQ-DI)
The patient reports the amount of difficulty they have in performing some of these activities like Dressing and grooming, Arising, Eating, Walking, Hygiene, Reach, Grip and Activities. Each question asks on a scale ranging from 0 to 3. If the categories performed without any difficulty (scale 0) up to cannot be done at all (scale 3)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Apr 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Md. Abu Shahin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Dr. Md Abu Shahiin, FCPS, MD, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827497
- Sponsor's protocol ID
- BSMMU/2022/10476
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fleischmann R, Schiff M, van der Heijde D, Ramos-Remus C, Spindler A, Stanislav M, Zerbini CA, Gurbuz S, Dickson C, de Bono S, Schlichting D, Beattie S, Kuo WL, Rooney T, Macias W, Takeuchi T. Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease-Modifying Antirheumatic Drug Treatment. Arthritis Rheumatol. 2017 Mar;69(3):506-517. doi: 10.1002/art.39953.
PubMed 27723271Islam N, Baron Basak T, OudeVoshaar MA, Ferdous N, Rasker JJ, Atiqul Haq S. Cross-cultural adaptation and validation of a Bengali Health Assessment Questionnaire for use in rheumatoid arthritis patients. Int J Rheum Dis. 2013 Aug;16(4):413-7. doi: 10.1111/1756-185X.12032. Epub 2013 Jan 22.
PubMed 23992261Yamaoka K. Janus kinase inhibitors for rheumatoid arthritis. Curr Opin Chem Biol. 2016 Jun;32:29-33. doi: 10.1016/j.cbpa.2016.03.006. Epub 2016 Mar 17.
PubMed 26994322
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baricitinib, Methotrexate as Monotherapy or Combination in the Treatment of Rheumatoid Arthritis - an Open Label Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05827497
- Acronym / sponsor ID
- BSMMU/2022/10476
- Conditions
- Rheumatoid Arthritis
- Keywords
- baricitinib, rheumatoid arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 25 Apr 2023 (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.
The goal of this open-label randomized clinical trial is to assess the efficacy of baricitinib 2 mg in comparison to methotrexate 25 mg as monotherapy followed by baricitinib 4 mg in comparison to methotrexate 10 mg and baricitinib 2 mg combination in patients with rheumatoid arthritis with moderate to severe disease activity. The main question it aims to answer:
- Is there any difference in the efficacy of baricitinib as monotherapy in comparison to methotrexate monotherapy or methotrexate-baricitinib combination in the treatment of rheumatoid arthritis
Detailed description
This open-label randomized clinical trial will be conducted in the department of rheumatology, BSMMU. The rheumatoid arthritis patients with moderate to high disease activity at baseline, disease activity score (DAS28ESR>3.2) will be considered as primary entry criteria for this study. Consecutive sampling method will be applied. The study will be done in 2 phases, duration of each phase 24 weeks. Considering inclusion and exclusion criteria, total 132 patients are randomized into group A and group B following block randomization. Each group will be consisting of 66 patients. In phase 1 Group A will be put on baricitinib 2 mg once daily and Group B will be put on methotrexate 25 mg weekly. The patients who fail to achieve remission or low disease activity by 24 weeks eligible for entry into phase 2 where group A will be put on baricitinib 4 mg and group B will be put on baricitinib 2 mg in combination with methotrexate 10 mg. Follow-up will be done at the 4th, 12th and 24th week in phase 1 and 28th, 36th and 48th week in phase 2. Response to treatment will be evaluated by DAS 28 ESR. At the end of 24th week endpoint for efficacy will be assessed at by DAS 28ESR. Adverse effects will be assessed by history, physical examinations and investigations.
Results will be compared among two groups with a 95% confidence interval and a p-value of < 0.05. The degrees of statistical significance between groups will be analyzed by unpaired t-test and/or Mann-Whitney U test. Qualitative data in between groups will be analyzed by the chi-square test. Probabilities of associations will be assessed by calculating Spearman´s rank correlation coefficient
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Baricitinib 2 MGbaricitinib 2 mg once daily |
| Group B | Active comparator | Drug: Methotrexate 25mgmethotrexate on 25 mg weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients more than 18 years of age 2. Patients fulfill the ACR/EULAR 2010 classification criteria for Rheumatoid arthritis 3. Patients with DAS 28 ESR> 3.2
Key exclusion criteria (1 listed)
- 1. Recent or concurrent infection including active tuberculosis 2. Haemoglobin (Hb) < 9 gm/dl 3. Total WBC count < 4000 / µL 4. Neutrophil count < 1200 / µL 5. Lymphocyte count < 750 / µL 6. AST/ALT > three times the upper limit of normal 7. Estimated glomerular filtration rate < 60 ml/minute/1.73 m2 8. Co-morbid illness- e.g., Malignancy 9 . Pregnant or breast feeding woman
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 |
|---|---|---|
| Baricitinib 2 MGAlso: Baricitinib 2mgbaricitinib 2 mg once daily | Drug | Group A |
| Methotrexate 25mg25mg daily | Drug | Group B |
Primary outcome
DAS 28 ESR
Time frame: 24 weeks
Following parameters are used to evaluate DAS28- Tender joint count Swollen joint count Patient global assessment (vas in cm) ESR/CRP
2 secondary outcomes
Clinical disease activity index (CDAI)
Time frame: 24 weeks
Health assessment questionnaire disability index (HAQ-DI)
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 27723271Fleischmann R, Schiff M, van der Heijde D, Ramos-Remus C, Spindler A, Stanislav M, Zerbini CA, Gurbuz S, Dickson C, de Bono S, Schlichting D, Beattie S, Kuo WL, Rooney T, Macias W, Takeuchi T. Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease-Modifying Antirheumatic Drug Treatment. Arthritis Rheumatol. 2017 Mar;69(3):506-517. doi: 10.1002/art.39953.
- Background: PubMed 23992261Islam N, Baron Basak T, OudeVoshaar MA, Ferdous N, Rasker JJ, Atiqul Haq S. Cross-cultural adaptation and validation of a Bengali Health Assessment Questionnaire for use in rheumatoid arthritis patients. Int J Rheum Dis. 2013 Aug;16(4):413-7. doi: 10.1111/1756-185X.12032. Epub 2013 Jan 22.
- Background: PubMed 26994322Yamaoka K. Janus kinase inhibitors for rheumatoid arthritis. Curr Opin Chem Biol. 2016 Jun;32:29-33. doi: 10.1016/j.cbpa.2016.03.006. Epub 2016 Mar 17.
- 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.
Dr. Md Abu Shahiin, FCPS, MD principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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 Baricitinib 2 MG and Methotrexate 25mg in people with Rheumatoid Arthritis, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh 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 1 inclusion and 1 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 25 Apr 2023. 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?
Contact Dr. Md Abu Shahin, FCPS, MD (+8801711313416, abushahinrh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS 28 ESR (time frame: 24 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 NCT05827497, which also lists 3 linked publications.
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 25 Apr 2023.