Spondyloarthritis, AxialPhase 2NCT06114407

Baricitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Comparison With Tofacitinib

A Phase 2 study testing Baricitinib 2mg and Tofacitinib 5 mg in people with Spondyloarthritis, Axial, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Axial Spondylarthritis (ax-SpA) is an important cause of inflammatory back pain in young adults. Janus kinase inhibitors (JAKi) has been approved for treatment of ax-SpA. Tofacitinib and baricitinib are drugs from same family (JAKi). Baricitinib is relatively less expensive than Tofacitinib. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Spondyloarthritis, Axial
What is being tested?: Baricitinib 2mg and Tofacitinib 5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 1 siteBangladesh
Study dates: 30 Oct 2023to 30 Dec 2024
Phase: Phase 2
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 ≥ 18 years
Patients meeting the ASAS classification criteria for axial spondyloarthritis
Patients fulfilling the definition of refractory axial spondyloarthritis
Patients with ASDAS-CRP ≥ 2.1

Who cannot join

Patients who are currently on treatment or had been previously treated with bDMARDs or tsDMARDS (including JAK inhibitors)
Hemoglobin < 9 gm/dl
WBC count < 4000/cmm, Neutrophil count < 1000 cmm, Platelet count < 100000/cmm
Any current or previous history of serious opportunistic infection including tuberculosis
Live vaccine within 3 months prior to the first dose
GFR < 50 ml/min

Show all 10Show fewer

ALT > 2 times upper limit normal
Pregnancy, breastfeeding or women of reproductive age group not using effective contraceptive
Current or previous history of malignancy, lymphoproliferative disease
New York Heart Association Class III and IV congestive heart failure

Trial locations and contacts

1 site in 1 country.

Samaresh Das, M B B S contact

+8801723224832

sam.dmc67@gmail.com

Bangladesh1 site, 1 recruiting

Bangabandhu Sheikh Mujib Medical University
Dhaka, 1000
Samaresh Das, M B B S, +8801723224832, sam.dmc67@gmail.com
Samaresh Das, M B B S
Recruiting

Other trials in Bangladesh

About this study

The goal of this non-inferiority clinical trial is to learn about the efficacy of baricitinib in refractory axial spondyloarthritis ( ax-SpA) and to compare its effect with that of tofacitinib. The main questions it aims to answer are:

Is baricitinib 4 mg effective in refractory ax-SpA?
Is baricitinib non-inferior to tofacitinib in refractory ax-SpA? Participants (treatment group, 92 patients) will be treated with baricitinib 2 mg twice daily for 12 weeks. Ninety two patients getting tofacitinib 10 mg/day (comparison group) will be taken as historical control from another study on the efficacy of tofacitinib in refractory ax-SpA?

Read the detailed description

This clinical trial will be conducted in the department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka from October 2023-March 2025. A total of 184 patients of both genders (age ≥18 years) with refractory ax-SpA meeting the inclusion and exclusion criteria will be enrolled in this study after having informed written consent. There will be two groups with 92 patients in each group. Treatment group (92 patients) will get baricitinib 4 mg daily. Ninety two patients getting tofacitinib 10 mg/day (control arm) will be taken as historical control from another ongoing study in this department. Patients of refractory ax-SpA with high disease activity (ASDAS-CRP≥2.1) will be the entry criteria in this study.

At baseline CBC, ESR, CRP, SGPT, Serum creatinine and X-ray SI joint (A/P view), HLA-B27(if needed), CXR P/A view and MT test, fasting lipid profile will be done. Baricitinib will be given to patients free of cost. Drug adherence will be ensured by monthly pill count. Follow up visit will be done at 4th and 12th week. At each follow up patients will be evaluated clinically, relevant laboratory test and will be assessed for any side effects. All the findings will be noted in a semi-structure questionnaire. At 12th week patients will be evaluated for efficacy. Outcome will be assessed by ASDAS CRP and a change of ≥ 1.1 units from baseline for clinically important improvement and≥ 2.0 units for major improvement. Disease activity will also be assessed by ASDAS-ESR, BASDAI, functional assessment by BASFI, spinal mobility by BASMI, pain, stiffness and patient global assessment by NRS, enthesitis byMASES, quality of life by Bangla version of SF-36, Bangla version of HAQ-DI and pilot Bangla version of ASQoL. Chi-square test will used for analysis of categorical variables. Comparison of the two groups will be done using independent t-test when the data are in normal distribution and Man-Whitney U test in case of skewed distribution. At 95% confidence interval P value < 0.05 will be considered statistically significant.

Each patient will be informed about the nature and purpose of the study. This study will be free from any undue benefits or influences. If any serious adverse events develop, drugs will be stopped and the patients will be treated with utmost care. Privacy, anonymity and confidentiality of every patient will be maintained in every step. Every patient will have the rights to participate and withdraw from the study at any point of time. The withdrawal of the patients will not alter their deserved medical care. Ethical clearance will be taken from Institutional Review Board (IRB) of BSMMU.

If baricitinib is found effective in refractory ax-SpA, it will decrease the treatment cost of the patients.

Conditions: Spondyloarthritis, Axial
Being tested: Baricitinib 2mg, Tofacitinib 5 mg
Keywords: Spondyloarthritis, Tofacitinib, Baricitinib, Refractory, Axial
Medical subject headings: Axial Spondyloarthritis, Spondylarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Baricitinib 2mgDrug
Also called Baritinib 2 mg
Participants of arm 'A' will be treated with tablet baricitinib 2 mg twice daily for 12 weeks
Tofacitinib 5 mgDrug
Also called Tofacent 5 mg
Participants of arm 'B' getting tablet tofacitinib 5 mg twice daily for 12 weeks will be taken as historical control arm from another study on the efficacy of tofacitinib in refractory axial spondyloarthritis

Study groups in NCT06114407
Study group	Role	What they receive
Baricitinib	Experimental	Participants of 'Baricitinib' arm will be treated with tablet baricitinib 2 mg twice daily for 12 weeks Receives: Drug: Baricitinib 2mg
Tofacitinib	Active comparator	Participants of 'Tofacininib' arm getting tablet tofacitinib 5 mg twice daily for 12 weeks will be taken as historical control arm from another study on the efficacy of tofacitinib in refractory axial spondyloarthritis Receives: Drug: Tofacitinib 5 mg

What is being measured

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

Ankylosing Spondylitis Disease Activity Score-C Reative Protein ( ASDAS-CRP)
To calculate ASDAS-CRP, besides the value of CRP, the four other items are back pain duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity (these are assessed by 0-10cm, visual analogue scale [VAS] or 0-10, numerical rating scale [NRS]).
Four disease activity states were categorized by ASAS: "inactive disease", "moderate disease activity", "high disease activity" and "very high disease activity".The 3 cut-offs chosen to separate these states are: <1.3 "inactive disease", 1.3 to <2.1 "low disease activity", 2.1 to <3.5 "high disease activity" and >3.5 "very high disease activity".
Patients of refractory ax-SpA with high disease activity (ASDAS-CRP≥2.1) will be the entry criteria in this study.
Primary outcome will be assessed by ASDAS CRP and a change of ≥ 1.1 units from baseline for clinically important improvement and ≥ 2.0 units for major improvement.
Measured: ASDAS CRP will be assessed at baseline, 4th and 12th week

Secondary outcomes (6)

Ankylosing Spondylitis Disease Activity Score-ESR ( ASDAS-ESR)
To calculate ASDAS-ESR, besides the value of ESR (mm/hr), the four other items are back pain duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity (these are assessed by 0-10cm, visual analogue scale [VAS] or 0-10, numerical rating scale [NRS]).
Four disease activity states were categorized by ASAS: "inactive disease", "moderate disease activity", "high disease activity" and "very high disease activity".The 3 cut-offs chosen to separate these states are: <1.3 "inactive disease", 1.3 to <2.1 "low disease activity", 2.1 to <3.5 "high disease activity" and >3.5 "very high disease activity".
Outcome will be assessed by ASDAS ESR and a change of ≥ 1.1 units from baseline for clinically important improvement and ≥ 2.0 units for major improvement.
Measured: ASDAS ESR will be assessed at baseline, 4th and 12th week
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI consists of a 01 through 10 scale (01 being no problem and 10 being worst problem) which is used to answer 6 questions pertaining to 5 major symptoms of AS: Fatigue, spinal pain, joint pain/ swelling, areas of localized tenderness ( also called enthesitis or inflammation of tendons or ligaments), morning stiffness duration, morning stiffness severity. The index results a final 0-10 BASDAI score.
Measured: BASDAI will be assessed at baseline, 4th and 12th week
Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI scores 10 items
1. Putting on your socks or tights without help or aids (eg, sock aid).
2. Bending forward from the waist to pick up a pen from the floor without an aid.
3. Reaching up to a high shelf without help or aids (eg, helping hand).
4. Getting up out of an armless dining room chair without using your hands or any other help.
5. Getting up off the floor without help from lying on your back.
6. Standing unsupported for 10 min without discomfort.
7. Climbing 12 to 15 steps without using a handrail or walking aid. One foot at each step.
8. Looking over your shoulder without turning your body.
9. Doing physically demanding activities (eg, physiotherapy, exercises, gardening or sports).
10. Doing a full day's activities, whether it be at home or at work. The BASFI is the mean of 10 item scores completed on a numerical rating scale. A Bangla validated version of BASFI will used in this study.
Measured: BASFI will be assessed at baseline, 4th and 12th week
Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI includes five clinical measurements that reflect axial mobility:
1. tragus to wall
2. lumbar flexion
3. cervical rotation
4. lumbar side flexion
5. intermalleolar distance.
Grading 0-10 or linear function. Total score 0-10.
Measured: BASMI will be assessed at baseline, 4th and 12th week
Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
MASES includes enthesitis at 13 Sites:
- Costochondral 1 right/left
- Costochondral 7 right/left
- Spina iliaca anterior superior right/left
- Crista iliaca right/left
- Spina iliaca posterior right/left
- Processus spinosus L5
- Achilles tendon, proximal insertion right/left. No grading All sites are scored as 0 or 1 The MASES is the sum of all site scores (from 0 to 13).
Measured: MASES will be assessed at baseline, 4th and 12th week
Ankylosing Spondylitis Quality of Life Questionnaire(ASQoL)
ASQoL includes 18 questions with response 'Yes' or 'No' scoring 01 or 0 respectively.
1. My condition limits the places I can go
2. I sometimes feel like crying
3. I have difficulty dressing
4. I struggle to do jobs around the house
5. It's impossible to sleep
6. I am unable to join in activities with my friends/family
7. I am tired all the time
8. I have to keep stopping what I am doing to rest
9. I have unbearable pain
10. It takes a long time to get going in the morning
11. I am unable to do jobs around the house
12. I get tired easily
13. I often get frustrated
14. The pain is always there
15. I feel I miss out on a lot
16. I find it difficult to wash my hair
17. My condition gets me down
18. I worry about letting people down All item scores are added to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL).
A Bangla version of ASQoL will be used in this study.
Measured: ASQoL will be assessed at baseline, 4th and 12th week

Timeline

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

30 Oct 202330 Dec 2024

First posted2 Nov 2023
Study start30 Oct 2023
Primary completion30 Jun 2024 (estimated)
Study completion30 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Spondyloarthritis, AxialStudies 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 184 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06114407
Sponsor's protocol ID: 4548
Status last verified: Dec 2023
First submitted: 28 Oct 2023
Last updated: 21 Dec 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Abdal SJ, Yesmin S, Shazzad MN, Azad MAK, Shahin MA, Choudhury MR, Islam MN, Haq SA. Development of a Bangla version of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI). Int J Rheum Dis. 2021 Jan;24(1):74-80. doi: 10.1111/1756-185X.14008. Epub 2020 Nov 1.
PubMed 33135389
Baraliakos X, Kiltz U, Peters S, Appel H, Dybowski F, Igelmann M, Kalthoff L, Krause D, Menne HJ, Saracbasi-Zender E, Schmitz-Bortz E, Vigneswaran M, Braun J. Efficiency of treatment with non-steroidal anti-inflammatory drugs according to current recommendations in patients with radiographic and non-radiographic axial spondyloarthritis. Rheumatology (Oxford). 2017 Jan;56(1):95-102. doi: 10.1093/rheumatology/kew367. Epub 2016 Oct 25.
PubMed 27997346
Deodhar A, Sliwinska-Stanczyk P, Xu H, Baraliakos X, Gensler LS, Fleishaker D, Wang L, Wu J, Menon S, Wang C, Dina O, Fallon L, Kanik KS, van der Heijde D. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2021 Aug;80(8):1004-1013. doi: 10.1136/annrheumdis-2020-219601. Epub 2021 Apr 27.
PubMed 33906853
Leung YY, Lee W, Lui NL, Rouse M, McKenna SP, Thumboo J. Adaptation of Chinese and English versions of the Ankylosing Spondylitis quality of life (ASQoL) scale for use in Singapore. BMC Musculoskelet Disord. 2017 Aug 17;18(1):353. doi: 10.1186/s12891-017-1715-x.
PubMed 28818056
Machado P, Landewe R, Lie E, Kvien TK, Braun J, Baker D, van der Heijde D; Assessment of SpondyloArthritis international Society. Ankylosing Spondylitis Disease Activity Score (ASDAS): defining cut-off values for disease activity states and improvement scores. Ann Rheum Dis. 2011 Jan;70(1):47-53. doi: 10.1136/ard.2010.138594. Epub 2010 Nov 10.
PubMed 21068095
Machado P, Navarro-Compan V, Landewe R, van Gaalen FA, Roux C, van der Heijde D. Calculating the ankylosing spondylitis disease activity score if the conventional c-reactive protein level is below the limit of detection or if high-sensitivity c-reactive protein is used: an analysis in the DESIR cohort. Arthritis Rheumatol. 2015 Feb;67(2):408-13. doi: 10.1002/art.38921.
PubMed 25332195
Miceli-Richard C, Dougados M. Tracking JAKs in spondyloarthritis: rationale and expectations. Ann Rheum Dis. 2017 Aug;76(8):1325-1326. doi: 10.1136/annrheumdis-2016-210886. Epub 2017 Mar 17. No abstract available.
PubMed 28314752
Ramiro S, Nikiphorou E, Sepriano A, Ortolan A, Webers C, Baraliakos X, Landewe RBM, Van den Bosch FE, Boteva B, Bremander A, Carron P, Ciurea A, van Gaalen FA, Geher P, Gensler L, Hermann J, de Hooge M, Husakova M, Kiltz U, Lopez-Medina C, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compan V, Nissen MJ, Pimentel-Santos FM, Poddubnyy D, Proft F, Rudwaleit M, Telkman M, Zhao SS, Ziade N, van der Heijde D. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023 Jan;82(1):19-34. doi: 10.1136/ard-2022-223296. Epub 2022 Oct 21.
PubMed 36270658
Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17.
PubMed 19297344
Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R, Dougados M, Hermann KG, Landewe R, Maksymowych W, van der Heijde D. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis. 2009 Jun;68 Suppl 2:ii1-44. doi: 10.1136/ard.2008.104018.
PubMed 19433414
Smith JA, Colbert RA. Review: The interleukin-23/interleukin-17 axis in spondyloarthritis pathogenesis: Th17 and beyond. Arthritis Rheumatol. 2014 Feb;66(2):231-41. doi: 10.1002/art.38291. No abstract available.
PubMed 24504793
Toussirot E. The Use of Janus Kinase Inhibitors in Axial Spondyloarthritis: Current Insights. Pharmaceuticals (Basel). 2022 Feb 22;15(3):270. doi: 10.3390/ph15030270.
PubMed 35337068
Veale DJ, McGonagle D, McInnes IB, Krueger JG, Ritchlin CT, Elewaut D, Kanik KS, Hendrikx T, Berstein G, Hodge J, Telliez JB. The rationale for Janus kinase inhibitors for the treatment of spondyloarthritis. Rheumatology (Oxford). 2019 Feb 1;58(2):197-205. doi: 10.1093/rheumatology/key070.
PubMed 29618084
Zahid-Al-Quadir A, Zaman MM, Ahmed S, Bhuiyan MR, Rahman MM, Patwary I, Das BB, Hossain SA, Paul S, Shahin A, Rahman M, Haq SA. Prevalence of musculoskeletal conditions and related disabilities in Bangladeshi adults: a cross-sectional national survey. BMC Rheumatol. 2020 Dec 16;4(1):69. doi: 10.1186/s41927-020-00169-w.
PubMed 33323124

Want to know more?

Samaresh Das, M B B S

+8801723224832

sam.dmc67@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Spondyloarthritis, Axial trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Baricitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Comparison With Tofacitinib
ClinicalTrials.gov ID: NCT06114407
Acronym / sponsor ID: 4548
Conditions: Spondyloarthritis, Axial
Keywords: Spondyloarthritis, Tofacitinib, Baricitinib, Refractory, Axial
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 184 participants (estimated)
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
Collaborators: Healthcare Pharmaceuticals
Study start: 30 Oct 2023 (actual)
Primary completion: 30 Jun 2024 (estimated)
Study completion: 30 Dec 2024 (estimated)
First posted: 2 Nov 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.

Is baricitinib 4 mg effective in refractory ax-SpA?
Is baricitinib non-inferior to tofacitinib in refractory ax-SpA? Participants (treatment group, 92 patients) will be treated with baricitinib 2 mg twice daily for 12 weeks. Ninety two patients getting tofacitinib 10 mg/day (comparison group) will be taken as historical control from another study on the efficacy of tofacitinib in refractory ax-SpA?

Detailed description

If baricitinib is found effective in refractory ax-SpA, it will decrease the treatment cost of the patients.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Baricitinib	Experimental	Drug: Baricitinib 2mgParticipants of 'Baricitinib' arm will be treated with tablet baricitinib 2 mg twice daily for 12 weeks
Tofacitinib	Active comparator	Drug: Tofacitinib 5 mgParticipants of 'Tofacininib' arm getting tablet tofacitinib 5 mg twice daily for 12 weeks will be taken as historical control arm from another study on the efficacy of tofacitinib in refractory axial spondyloarthritis

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥ 18 years
Patients meeting the ASAS classification criteria for axial spondyloarthritis
Patients fulfilling the definition of refractory axial spondyloarthritis
Patients with ASDAS-CRP ≥ 2.1

Key exclusion criteria (10 listed)

Patients who are currently on treatment or had been previously treated with bDMARDs or tsDMARDS (including JAK inhibitors)
Hemoglobin < 9 gm/dl
WBC count < 4000/cmm, Neutrophil count < 1000 cmm, Platelet count < 100000/cmm
Any current or previous history of serious opportunistic infection including tuberculosis
Live vaccine within 3 months prior to the first dose

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 2mgAlso: Baritinib 2 mgParticipants of arm 'A' will be treated with tablet baricitinib 2 mg twice daily for 12 weeks	Drug	Baricitinib
Tofacitinib 5 mgAlso: Tofacent 5 mgParticipants of arm 'B' getting tablet tofacitinib 5 mg twice daily for 12 weeks will be taken as historical control arm from another study on the efficacy of tofacitinib in refractory axial spondyloarthritis	Drug	Tofacitinib

Primary outcome

Ankylosing Spondylitis Disease Activity Score-C Reative Protein ( ASDAS-CRP)
Time frame: ASDAS CRP will be assessed at baseline, 4th and 12th week
To calculate ASDAS-CRP, besides the value of CRP, the four other items are back pain duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity (these are assessed by 0-10cm, visual analogue scale [VAS] or 0-10, numerical rating scale [NRS]). Four disease activity states were categorized by ASAS: "inactive disease", "moderate disease activity", "high disease activity" and "very high disease activity".The 3 cut-offs chosen to separate these states are: <1.3 "inactive disease", 1.3 to <2.1 "low disease activity", 2.1 to <3.5 "high disease activity" and >3.5 "very high disease activity". Patients of refractory ax-SpA with high disease activity (ASDAS-CRP≥2.1) will be the entry criteria in this study. Primary outcome will be assessed by ASDAS CRP and a change of ≥ 1.1 units from baseline for clinically important improvement and ≥ 2.0 units for major improvement.

6 secondary outcomes

Ankylosing Spondylitis Disease Activity Score-ESR ( ASDAS-ESR)
Time frame: ASDAS ESR will be assessed at baseline, 4th and 12th week
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: BASDAI will be assessed at baseline, 4th and 12th week
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: BASFI will be assessed at baseline, 4th and 12th week
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: BASMI will be assessed at baseline, 4th and 12th week
Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Time frame: MASES will be assessed at baseline, 4th and 12th week
Ankylosing Spondylitis Quality of Life Questionnaire(ASQoL)
Time frame: ASQoL will be assessed at baseline, 4th and 12th week

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
Background: PubMed 33135389Abdal SJ, Yesmin S, Shazzad MN, Azad MAK, Shahin MA, Choudhury MR, Islam MN, Haq SA. Development of a Bangla version of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI). Int J Rheum Dis. 2021 Jan;24(1):74-80. doi: 10.1111/1756-185X.14008. Epub 2020 Nov 1.
Background: PubMed 27997346Baraliakos X, Kiltz U, Peters S, Appel H, Dybowski F, Igelmann M, Kalthoff L, Krause D, Menne HJ, Saracbasi-Zender E, Schmitz-Bortz E, Vigneswaran M, Braun J. Efficiency of treatment with non-steroidal anti-inflammatory drugs according to current recommendations in patients with radiographic and non-radiographic axial spondyloarthritis. Rheumatology (Oxford). 2017 Jan;56(1):95-102. doi: 10.1093/rheumatology/kew367. Epub 2016 Oct 25.
Background: PubMed 33906853Deodhar A, Sliwinska-Stanczyk P, Xu H, Baraliakos X, Gensler LS, Fleishaker D, Wang L, Wu J, Menon S, Wang C, Dina O, Fallon L, Kanik KS, van der Heijde D. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2021 Aug;80(8):1004-1013. doi: 10.1136/annrheumdis-2020-219601. Epub 2021 Apr 27.
Background: PubMed 28818056Leung YY, Lee W, Lui NL, Rouse M, McKenna SP, Thumboo J. Adaptation of Chinese and English versions of the Ankylosing Spondylitis quality of life (ASQoL) scale for use in Singapore. BMC Musculoskelet Disord. 2017 Aug 17;18(1):353. doi: 10.1186/s12891-017-1715-x.
Background: PubMed 21068095Machado P, Landewe R, Lie E, Kvien TK, Braun J, Baker D, van der Heijde D; Assessment of SpondyloArthritis international Society. Ankylosing Spondylitis Disease Activity Score (ASDAS): defining cut-off values for disease activity states and improvement scores. Ann Rheum Dis. 2011 Jan;70(1):47-53. doi: 10.1136/ard.2010.138594. Epub 2010 Nov 10.
Background: PubMed 25332195Machado P, Navarro-Compan V, Landewe R, van Gaalen FA, Roux C, van der Heijde D. Calculating the ankylosing spondylitis disease activity score if the conventional c-reactive protein level is below the limit of detection or if high-sensitivity c-reactive protein is used: an analysis in the DESIR cohort. Arthritis Rheumatol. 2015 Feb;67(2):408-13. doi: 10.1002/art.38921.
Background: PubMed 28314752Miceli-Richard C, Dougados M. Tracking JAKs in spondyloarthritis: rationale and expectations. Ann Rheum Dis. 2017 Aug;76(8):1325-1326. doi: 10.1136/annrheumdis-2016-210886. Epub 2017 Mar 17. No abstract available.
Background: PubMed 36270658Ramiro S, Nikiphorou E, Sepriano A, Ortolan A, Webers C, Baraliakos X, Landewe RBM, Van den Bosch FE, Boteva B, Bremander A, Carron P, Ciurea A, van Gaalen FA, Geher P, Gensler L, Hermann J, de Hooge M, Husakova M, Kiltz U, Lopez-Medina C, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compan V, Nissen MJ, Pimentel-Santos FM, Poddubnyy D, Proft F, Rudwaleit M, Telkman M, Zhao SS, Ziade N, van der Heijde D. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023 Jan;82(1):19-34. doi: 10.1136/ard-2022-223296. Epub 2022 Oct 21.
Background: PubMed 19297344Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17.
Background: PubMed 19433414Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R, Dougados M, Hermann KG, Landewe R, Maksymowych W, van der Heijde D. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis. 2009 Jun;68 Suppl 2:ii1-44. doi: 10.1136/ard.2008.104018.
Background: PubMed 24504793Smith JA, Colbert RA. Review: The interleukin-23/interleukin-17 axis in spondyloarthritis pathogenesis: Th17 and beyond. Arthritis Rheumatol. 2014 Feb;66(2):231-41. doi: 10.1002/art.38291. No abstract available.
Background: PubMed 35337068Toussirot E. The Use of Janus Kinase Inhibitors in Axial Spondyloarthritis: Current Insights. Pharmaceuticals (Basel). 2022 Feb 22;15(3):270. doi: 10.3390/ph15030270.

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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.

Samaresh Das, M B B S contact

+8801723224832

sam.dmc67@gmail.com

Samaresh Das, M B B S 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 2 study testing Baricitinib 2mg and Tofacitinib 5 mg in people with Spondyloarthritis, Axial, 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 4 inclusion and 10 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 21 Dec 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Samaresh Das, M B B S (+8801723224832, sam.dmc67@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ankylosing Spondylitis Disease Activity Score-C Reative Protein ( ASDAS-CRP) (time frame: ASDAS CRP will be assessed at baseline, 4th and 12th week). 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 NCT06114407, which also lists 14 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 21 Dec 2023.