SpondyloarthritisPhase 4NCT03504072
Risk of Tuberculous and Other Infections in Patients of Spondyloarthritis Treated With Tofacitinib in Bangladesh
A Phase 4 study testing Tofacitinib 5 mg, and Etanercept in people with Spondyloarthritis, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Treatment failure of Spondyloarthropathies (SpA) leads to marked functional disability, higher rates of morbidity, mortality and poor quality of life. In TB endemic countries effective and safe drugs are to be in hand to manage this group of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- Tofacitinib 5 mg, and Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteBangladesh
- Study dates
- 16 Jan 2018to 31 Dec 2019
- 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
- IBP criteria (4 out of 5 parameters present more than 3 months) Inflammatory back pain 1) Age of onset <45 yr 2) Insidious onset 3) Improvement with exercise 4) No improvement with rest 5) Pain at night (with improvement upon arising)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of > 4 (range, 0-10)
- Failing to response to 2 NSAIDs in full therapeutic dose or withdrawal for intolerance in four consecutive weeks
- Age > 18 years
- Agreed to participate in the study
Who cannot join
- Known case of allergic patients
- Pregnancy
- Patient with any active or history of any chronic or recurrent or serious or opportunistic infection/sepsis
- Known case of chronic kidney disease (Cl cr <40 mL/minute)
- Moderate to severe liver disease of any type
- Lymphopenia (Lymphocyte <500 cells/mm3 of blood)
Show all 11Show fewer
- Neutropenia (Neutrophil <1000 cells/mm3 of blood)
- Anaemia (Hb < 9 g/dl)
- Who have been exposed to tuberculosis
- Chest X-ray suggestive of pulmonary tuberculosis
- Patients who do not want to participate in this study
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
Bangabandhu Sheikh Mujib Medical University
Dhaka
Nazrul Islam, FCPS, MD
About this study
Official title: Risk of Tuberculosis and Infections in Spondyloarthritis Patients Treated With Tofacitinib in Bangladesh
Treatment failure of Spondyloarthropathies (SpA) leads to marked functional disability, higher rates of morbidity, mortality and poor quality of life. In TB endemic countries effective and safe drugs are to be in hand to manage this group of patients. The aim of this study will be to evaluation the risk of tuberculosis and other infections in refractory SpA patients treated with tofacitinib. After having consent 174 adults will be enrolled. Follow up period will be 9 months (visits 0, 1, 3, 6 and 9). Study subjects (87) will receive tofacitinib (5 mg 12 hourly). Control patients will get etanercept (50 mg subcutaneously every 7 days interval for 1st month then 50 mg in 15 days interval for 2nd month then 50 mg every 21 days interval till final visit.
Treatment efficacy assessment tool will be BASDAI, ASDAS-ESR, ASDAS-CRP and ASQoL for quality of life. Occurrences of tuberculosis and serious infection will be the primary end point of this study. The quantitative variables like ESR, CRP, BASDAI, ASDAS-ESR, ASDAS-CRP and ASQoL scores will be computed as mean and SD. Occurrences of TB and infection will be expressed in number and percentage. In between groups according to data distribution, students't test or ManWhitny U test will be done. The P value <0.05 will be considered significant. Each patient will enjoy every right to participate or refuse or even withdraw from the study at any point of time. Anonymity and data confidentiality will be maintained strictly. Ethical clearance will be obtained from Institutional Review Board (IRB) of BSMMU.
The expected utility of this study will be; a) reporting on occurrence of TB and other infections in SpA patients with tofacitinib and etanercept, b) if identified safe and effective physician can use the agents without fear, c) for dose spacing of etanercept the cumulative dose will be low might make the drug affordable and also reduce the risk of TB and other infections, d) for spaced follow up schedule there will be minimized physician visit, lab testing etc.
Read the detailed description
Spondyloarthropathies (SpA) are non curable, diseases of young subjects, treatment failure leads to marked functional disability, higher rates of morbidity, mortality and poor quality of life. Effective drugs may not be safe in different geographic backgrounds. Bangladesh is a TB endemic country so patients are at risk of TB and other infections at background. The aim of this study will be to evaluation the risk of tuberculosis and other infections in refractory SpA patients treated with tofacitinib.
In this randomized clinical trial a total 174 adults will be enrolled from BSMMU and other hospitals of Dhaka city. The study period will be from January 2018 to December 2019. Subjects of both gender (≥18 years), who fulfil inclusion criteria will be enrolled after having informed written consent. Follow up period will be 9 months (visits 0, 1, 3, 6 and 9). Study subjects (87) will receive tofacitinib (5 mg 12 hourly). Control patients will get etanercept (50 mg subcutaneously every 7 days interval for 1st month then 50 mg in 15 days interval for 2nd month then 50 mg every 21 days interval till final visit. Demographics, clinical and lab information will be recorded in semi-structured schedule. Treatment efficacy assessment tool will be BASDAI, ASDAS-ESR, ASDAS-CRP and ASQoL for quality of life. Relevant lab test will be done at follow up visits. Side effects will be recorded in the research schedule. Occurrences of tuberculosis and serious infection will be the primary end point of this study. The demographics and categorical outcomes will be expressed in number and percentage. The quantitative variables like ESR, CRP, BASDAI, ASDAS-ESR, ASDAS-CRP and ASQoL scores will be computed as mean and SD. Occurrences of TB and infection will be expressed in number and percentage. Within group the quantitative data of baseline and of final visit will be analyzed using independent sample t test. In between groups according to data distribution, students't test or ManWhitny U test will be done. The P value <0.05 will be considered significant. Each patient will enjoy every right to participate or refuse or even withdraw from the study at any point of time. The study drugs are widely used agents in abroad for different rheumatic conditions having acceptable safety profile with efficacy as such there will be no extra risk of study subjects. Anonymity and data confidentiality will be maintained strictly. Ethical clearance will be obtained from Institutional Review Board (IRB) of BSMMU.
The expected utility of this study will be; a) reporting on occurrence of TB and other infections in SpA patients with tofacitinib and etanercept, b) if identified safe and effective physician can use the agents without fear, c) for dose spacing of etanercept the cumulative dose will be low might make the drug affordable and also reduce the risk of TB and other infections, d) for spaced follow up schedule there will be minimized physician visit, lab testing etc.
- Conditions
- Spondyloarthritis
- Being tested
- Tofacitinib 5 mg,, Etanercept
- Keywords
- Etanercept, Infection, Tofacitinib, Tuberculosis, Spondyloarthritis
- Medical subject headings
- Spondylarthritis, Infections, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib 5 mg,Drug
Also called tofacitinib
tofacitinib 5 mg 12 hourly daily for 9 months
EtanerceptDrug
Also called Etanercept 50 mg
Etanercept 50 mg sc every 7 days interval in 1st month, every 15 days interval in 2nd month and then every 21 days interval from 3rd month onward upto 9 months
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib 5mg | Active comparator | tofacitinib 5 mg 12 hourly daily for 9 months. Evaluation schedule will be baseline, 1st month, 3rd months and 3 monthly for 9 months. relevant investigations will be done at each visit. occurrence of tuberculosis and infections will be recorded at follow up visits. Receives: Drug: Tofacitinib 5 mg, |
| Etanercept 50 mg | Active comparator | Etanercept 50 mg subcutaneously every 7 days interval for 1st month then, Etanercept 50 mg in 15 days interval for 2nd month then 50 mg every 21 days interval for 9 months. Occurrence of tuberculosis and infections will be recorded at follow up visits. Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Tuberculosis
While on trial drug occurrence of tuberculosis either pulmonary or extra pulmonary
Measured: 9th months
Secondary outcomes (1)
improvement of disease activity measures of spondyloarthritis by >40%
>40% improvement in at least 4 of the following 5 parameters: Patient global assessment, Pain, Function, Morning stiffness, Spinal mobility, C- reactive protein
- Patient global assessment
- Pain
- Function
- Morning stiffness
- Spinal mobility C- reactive protein
Measured: at 9th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start16 Jan 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Follow up period will be 9 months (visits 0, 1, 3, 6 and 9). Study subjects (87) will receive toficitinib (5 mg 12 hourly). Control patients will get eternacept (50 mg subcutaneously every 7 days interval for 1st month then 50 mg in 15 days interval for 2nd month then 50 mg every 21 days interval till final visit.
- Masking
- None (open label)
- Enrolment
- 174 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. Nazrul Islam, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Shaikh A Al Mamun, MBBS, Study chair, Member secretary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504072
- Sponsor's protocol ID
- 2018/547
- Status last verified
- Apr 2018
- First submitted
- 29 Mar 2018
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Tuberculosis and Infections in Spondyloarthritis Patients Treated With Tofacitinib in Bangladesh
- ClinicalTrials.gov ID
- NCT03504072
- Acronym / sponsor ID
- 2018/547
- Conditions
- Spondyloarthritis
- Keywords
- Etanercept, Infection, Tofacitinib, Tuberculosis, Spondyloarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 20 Apr 2018 (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.
Treatment failure of Spondyloarthropathies (SpA) leads to marked functional disability, higher rates of morbidity, mortality and poor quality of life. In TB endemic countries effective and safe drugs are to be in hand to manage this group of patients. The aim of this study will be to evaluation the risk of tuberculosis and other infections in refractory SpA patients treated with tofacitinib. After having consent 174 adults will be enrolled. Follow up period will be 9 months (visits 0, 1, 3, 6 and 9). Study subjects (87) will receive tofacitinib (5 mg 12 hourly). Control patients will get etanercept (50 mg subcutaneously every 7 days interval for 1st month then 50 mg in 15 days interval for 2nd month then 50 mg every 21 days interval till final visit.
Treatment efficacy assessment tool will be BASDAI, ASDAS-ESR, ASDAS-CRP and ASQoL for quality of life. Occurrences of tuberculosis and serious infection will be the primary end point of this study. The quantitative variables like ESR, CRP, BASDAI, ASDAS-ESR, ASDAS-CRP and ASQoL scores will be computed as mean and SD. Occurrences of TB and infection will be expressed in number and percentage. In between groups according to data distribution, students't test or ManWhitny U test will be done. The P value <0.05 will be considered significant. Each patient will enjoy every right to participate or refuse or even withdraw from the study at any point of time. Anonymity and data confidentiality will be maintained strictly. Ethical clearance will be obtained from Institutional Review Board (IRB) of BSMMU.
The expected utility of this study will be; a) reporting on occurrence of TB and other infections in SpA patients with tofacitinib and etanercept, b) if identified safe and effective physician can use the agents without fear, c) for dose spacing of etanercept the cumulative dose will be low might make the drug affordable and also reduce the risk of TB and other infections, d) for spaced follow up schedule there will be minimized physician visit, lab testing etc.
Detailed description
Spondyloarthropathies (SpA) are non curable, diseases of young subjects, treatment failure leads to marked functional disability, higher rates of morbidity, mortality and poor quality of life. Effective drugs may not be safe in different geographic backgrounds. Bangladesh is a TB endemic country so patients are at risk of TB and other infections at background. The aim of this study will be to evaluation the risk of tuberculosis and other infections in refractory SpA patients treated with tofacitinib.
In this randomized clinical trial a total 174 adults will be enrolled from BSMMU and other hospitals of Dhaka city. The study period will be from January 2018 to December 2019. Subjects of both gender (≥18 years), who fulfil inclusion criteria will be enrolled after having informed written consent. Follow up period will be 9 months (visits 0, 1, 3, 6 and 9). Study subjects (87) will receive tofacitinib (5 mg 12 hourly). Control patients will get etanercept (50 mg subcutaneously every 7 days interval for 1st month then 50 mg in 15 days interval for 2nd month then 50 mg every 21 days interval till final visit. Demographics, clinical and lab information will be recorded in semi-structured schedule. Treatment efficacy assessment tool will be BASDAI, ASDAS-ESR, ASDAS-CRP and ASQoL for quality of life. Relevant lab test will be done at follow up visits. Side effects will be recorded in the research schedule. Occurrences of tuberculosis and serious infection will be the primary end point of this study. The demographics and categorical outcomes will be expressed in number and percentage. The quantitative variables like ESR, CRP, BASDAI, ASDAS-ESR, ASDAS-CRP and ASQoL scores will be computed as mean and SD. Occurrences of TB and infection will be expressed in number and percentage. Within group the quantitative data of baseline and of final visit will be analyzed using independent sample t test. In between groups according to data distribution, students't test or ManWhitny U test will be done. The P value <0.05 will be considered significant. Each patient will enjoy every right to participate or refuse or even withdraw from the study at any point of time. The study drugs are widely used agents in abroad for different rheumatic conditions having acceptable safety profile with efficacy as such there will be no extra risk of study subjects. Anonymity and data confidentiality will be maintained strictly. Ethical clearance will be obtained from Institutional Review Board (IRB) of BSMMU.
The expected utility of this study will be; a) reporting on occurrence of TB and other infections in SpA patients with tofacitinib and etanercept, b) if identified safe and effective physician can use the agents without fear, c) for dose spacing of etanercept the cumulative dose will be low might make the drug affordable and also reduce the risk of TB and other infections, d) for spaced follow up schedule there will be minimized physician visit, lab testing etc.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Follow up period will be 9 months (visits 0, 1, 3, 6 and 9). Study subjects (87) will receive toficitinib (5 mg 12 hourly). Control patients will get eternacept (50 mg subcutaneously every 7 days interval for 1st month then 50 mg in 15 days interval for 2nd month then 50 mg every 21 days interval till final visit.
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib 5mg | Active comparator | Drug: Tofacitinib 5 mg,tofacitinib 5 mg 12 hourly daily for 9 months. Evaluation schedule will be baseline, 1st month, 3rd months and 3 monthly for 9 months. relevant investigations will be done at each visit. occurrence of tuberculosis and infections will be recorded at follow up visits. |
| Etanercept 50 mg | Active comparator | Drug: EtanerceptEtanercept 50 mg subcutaneously every 7 days interval for 1st month then, Etanercept 50 mg in 15 days interval for 2nd month then 50 mg every 21 days interval for 9 months. Occurrence of tuberculosis and infections will be recorded at follow up visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- IBP criteria (4 out of 5 parameters present more than 3 months) Inflammatory back pain 1) Age of onset <45 yr 2) Insidious onset 3) Improvement with exercise 4) No improvement with rest 5) Pain at night (with improvement upon arising)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of > 4 (range, 0-10)
- Failing to response to 2 NSAIDs in full therapeutic dose or withdrawal for intolerance in four consecutive weeks
- Age > 18 years
- Agreed to participate in the study
Key exclusion criteria (11 listed)
- Known case of allergic patients
- Pregnancy
- Patient with any active or history of any chronic or recurrent or serious or opportunistic infection/sepsis
- Known case of chronic kidney disease (Cl cr <40 mL/minute)
- Moderate to severe liver disease of any type
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 |
|---|---|---|
| Tofacitinib 5 mg,Also: tofacitinibtofacitinib 5 mg 12 hourly daily for 9 months | Drug | Tofacitinib 5mg |
| EtanerceptAlso: Etanercept 50 mgEtanercept 50 mg sc every 7 days interval in 1st month, every 15 days interval in 2nd month and then every 21 days interval from 3rd month onward upto 9 months | Drug | Etanercept 50 mg |
Primary outcome
Occurrence of Tuberculosis
Time frame: 9th months
While on trial drug occurrence of tuberculosis either pulmonary or extra pulmonary
1 secondary outcome
improvement of disease activity measures of spondyloarthritis by >40%
Time frame: at 9th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- 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.
Shaikh A Al Mamun, MBBS study chair
Member secretary
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 Tofacitinib 5 mg, and Etanercept in people with Spondyloarthritis, 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 5 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: status not confirmed, as of the sponsor's last update on 23 Apr 2018. 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 Nazrul N Islam, FCPS, MD (8801678112396, islam1nazrul@gmail.com, islam1nazrul@bsmmu.edu.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Tuberculosis (time frame: 9th months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2018.