AzTrials
AzTrials

Rheumatoid ArthritisPhase 4NCT05660655

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

A Phase 4 study testing Baricitinib 4 MG Oral Tablet and Baricitinib 2 MG in people with Rheumatoid Arthritis, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. 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?
Baricitinib 4 MG Oral Tablet and Baricitinib 2 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteBangladesh
Study dates
1 Oct 2022to 30 Sep 2023
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

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • Dr. Md. Sadikul islam

    Dhaka, [Other], 1207

Other trials in Bangladesh

About this study

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

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.

Read the detailed 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

Being tested
Baricitinib 4 MG Oral Tablet, Baricitinib 2 MG
Keywords
baricitinib, RA, JAKi
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 4 MG Oral TabletDrug

    Also called for group B

    baricitinib 4 mg once daily

  • Baricitinib 2 MGDrug

    Also called for group A

    baricitinib 4mg once daily in group A

Study groups in NCT05660655
Study groupRoleWhat they receive
Baricitinib 2mg and methotrexate 10mgActive comparatorBaricitinib 2mg once daily plus methotrexate 10mg per week
Receives: Drug: Baricitinib 2 MG
Baricitinib 4mg and methotrexate 10mgExperimentalBaricitinib 4mg once daily plus methotrexate 10mg per week
Receives: Drug: Baricitinib 4 MG Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

Secondary outcomes (3)

  1. 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

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start1 Oct 2022
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

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
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05660655
Sponsor's protocol ID
BSMMU/2022/11646
Status last verified
Nov 2023
First submitted
13 Dec 2022
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29415145

  • 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 27723271

  • 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: results from the RA-BUILD study. Ann Rheum Dis. 2017 Jan;76(1):88-95. doi: 10.1136/annrheumdis-2016-210094. Epub 2016 Sep 29.

    PubMed 27689735

  • Islam MS, Choudhury MR, Azad MAK, Shahin MA, Haq SA, Hossain SMZ, Khan NA, Rahman MA. Baricitinib in moderate to severe rheumatoid arthritis: dose-dependent efficacy and safety in a randomized clinical trial in a developing country. BMC Rheumatol. 2026 Mar 30;10(1):41. doi: 10.1186/s41927-026-00638-8.

    PubMed 41913302

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Baricitinib 4 MG Oral Tablet and Baricitinib 2 MG 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 3 inclusion and 11 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 18 Nov 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?

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?

Disease activity score 28-C-reactive protein (DAS28-CRP) (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 NCT05660655, which also lists 4 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 18 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in