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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05660655
• Other study ID #: BSMMU/2022/11646
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age greater than 18 years

2. patients fulfill the ACR/EULAR 2010 classification criteria for RA

3. DAS-28 CRP more than 3.2 despite optimum dose of methotrexate

Exclusion Criteria:

1. Recent or concurrent infection including active or latent tuberculosis except patients with latent tuberculosis in whom treatment was commenced = 4 weeks before randomization

2. Hemoglobin (Hb) < 8 g/dl

3. White blood cell count < 4000, Neutrophil count < 1000, Platelet count < 100000/mm3

4. Live vaccines within 3 months prior to the first dose

5. Serum creatinine > upper limit of normal reference range

6. eGFR < 60 ml/minute/1.73 m2

7. Alanine transaminase (ALT) more than ULN

8. Pregnant or breast feeding females of child-bearing potential

9. 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

10. New York Heart Association Class III and IV congestive heart failure

11. Previous history of thromboembolism, deep venous thrombosis, diverticulitis

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Baricitinib 4 MG Oral Tablet
baricitinib 4 mg once daily
• Baricitinib 2 MG
baricitinib 4mg once daily in group A

Locations

Country	Name	City	State
Bangladesh	Dr. Md. Sadikul islam	Dhaka	[Other]

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

References & Publications (3)

Dougados M, van der Heijde D, Chen YC, Greenwald M, Drescher E, Liu J, Beattie S, Witt S, de la Torre I, Gaich C, Rooney T, Schlichting D, de Bono S, Emery P. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs — View Citation

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 Rhe — View Citation

Genovese MC, Kremer JM, Kartman CE, Schlichting DE, Xie L, Carmack T, Pantojas C, Sanchez Burson J, Tony HP, Macias WL, Rooney TP, Smolen JS. Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis. Rheumatology (Oxford). 2018 May 1;57(5):900-908. doi: 10.1093/rheumatology/kex489. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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