CompletedPhase 3

Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh

Bangladesh93 participantsStarted 2017-01-01

Plain-language summary

the present study was conducted to determine the comparative efficacy and safety of thalidomide and SSZ in moderate to severe cases of ankylosing spondylitis in Bangladesh.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The present study included patients aged \>18 years with inflammatory low back pain fulfilling the Modified New York criteria for moderate to severe ankylosing spondylitis. The criteria include radiographic sacroiliitis (at least grade II bilaterally or grade III unilaterally) along with clinical signs, such as inflammatory back pain for at least 3 months' duration, limitation of lumbar spine in sagittal and frontal planes, or chest expansion decreased relative to normal values for age and sex Exclusion Criteria: * Exclusion criteria were non-inflammatory back pain or back pain due to inflammatory causes other than AS, failure to confirm a washout period of four weeks, those, those who were on DMARDs, allergy to thalidomide, sulphasalazine, and NSAIDs, known to have kidney diseases or cardiac disease, active peptic ulcer disease, and pregnancy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

BASDAI

Timeframe: Outcome 1: "Bath Ankylosing Spondylitis Disease Activity index(BASDAI) pain score at baseline"; Outcome 2: " "Bath Ankylosing Spondylitis Disease Activity index(BASDAI) pain score at week 12""

Trial details

NCT IDNCT06985134

SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-31

View on ClinicalTrials.gov More Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.