Efficacy and Safety of Baricitinib for the Treatment of Moderate to Severe Rheumatoid Arthritis

Study Overview
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Brief Summary
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This is a randomized controlled study. Baricitinib 4mg in one arm and Baricitinib 2mg in another arm will be used. Methotrexate 10mg per week in both arms will be used.

Detailed Description
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This open label randomized controlled clinical trial will be conducted in the department of Rheumatology, BSMMU. The rheumatoid arthritis patients with moderate to severe disease activity (DAS 28 ESR/CRP>3.2) despite treatment with methotrexate or other csDMARDs will be considered as primary entry criteria for this study. Simple random sampling method will be applied. After a washout period of three weeks, Group A will be put on baricitinib 2 mg once daily and Group B will be put on baricitinib 4 mg once daily. Methotrexate 10mg will be used on both groups in addition to barcitinib. NSAIDs and adjuvant analgesics will be used if needed. All the patients will go through baseline evaluation before treatment which include-Disease Activity Score derivative for 28 joints (DAS 28ESR/CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Health Assessment Questionnaire-Disability Index (HAQ-DI) and laboratory tests like CBC, CRP, SGPT, Serum Creatinine, LDH, RF, ACPA, Chest X-ray P/A view and TST or interferon gamma release assay (IGRA). Follow up will be done at 4th, 12th and 24th week. Response to treatment will be evaluated by DAS 28 ESR/CRP. Primary endpoint for efficacy will be assessed at the end of 24th week by DAS 28 CRP response. Secondary endpoints will be determined by SDAI, CDAI and HAQ-DI. Adverse effects will be assessed by history, physical examinations and investigations

Official Title
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Efficacy and Safety of Baricitinib in Different Doses for the Treatment of Moderate to Severe Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Baricitinib 4 MG Oral Tablet
* Drug: Baricitinib 2 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age greater than 18 years patients fulfill the ACR/EULAR 2010 classification criteria for RA DAS-28 CRP more than 3.2 despite optimum dose of methotrexate Exclusion Criteria: Recent or concurrent infection including active or latent tuberculosis except patients with latent tuberculosis in whom treatment was commenced ≥ 4 weeks before randomization Hemoglobin (Hb) < 8 g/dl White blood cell count < 4000, Neutrophil count < 1000, Platelet count < 100000/mm3 Live vaccines within 3 months prior to the first dose Serum creatinine > upper limit of normal reference range eGFR < 60 ml/minute/1.73 m2 Alanine transaminase (ALT) more than ULN Pregnant or breast feeding females of child-bearing potential Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ New York Heart Association Class III and IV congestive heart failure Previous history of thromboembolism, deep venous thrombosis, diverticulitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Baricitinib 2mg and methotrexate 10mg<br>Baricitinib 2mg once daily plus methotrexate 10mg per week | Drug: Baricitinib 2 MG<br>* baricitinib 4mg once daily in group A<br>* Other names: for group A;|
| Experimental: Baricitinib 4mg and methotrexate 10mg<br>Baricitinib 4mg once daily plus methotrexate 10mg per week | Drug: Baricitinib 4 MG Oral Tablet<br>* baricitinib 4 mg once daily<br>* Other names: for group B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity score 28-C-reactive protein (DAS28-CRP) | Disease activity score in 28 joints has to measure at 6 months. score less than or equal 3.2 will be regarded as low disease activity | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Disease activity index (CDAI) | clinical disease activity index at 6 months will be recorded. Score of equal or less than 10 will be regarded as low disease activity | 6 months | 
| Health Assessment Questionnaire-Disability Index (HAQ-DI) | health assesment by HAQ-DI at 6 months will be recorded. reduction of more than 0.22 will be regarded as improvement. | 6 months | 
| Disease activity score 28-C-reactive protein (DAS28-CRP) | Disease activity score in 28 joints has to measure at 6 months. score less than or equal 3.2 will be regarded as low disease activity | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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baricitinib, RA, JAKi