Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From BangladeshPhase 3NCT06985134

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

A Phase 3 study testing Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study from Bangladesh in people with Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh and Condition ...Moderate to Severe Axial Spondyloarthopathy, 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

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh, Condition ...Moderate to Severe Axial Spondyloarthopathy
What is being tested?: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study from Bangladesh
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 1 siteBangladesh
Study dates: 1 Jan 2017to 31 Dec 2018
Phase: Phase 3
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

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

Bsmmu
Dhaka, Shahbag, 1000

Other trials in Bangladesh

About this study

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.

Conditions: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh, Condition ...Moderate to Severe Axial Spondyloarthopathy
Being tested: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study from Bangladesh

What participants receive

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

Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study from BangladeshDrug
The present study included patients aged >18 years with inflammatory low back pain fulfilling the Modified New York criteria [12], 2014 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 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 who were on DMARDs, allergy to thalidomide, Sulfasalazine, and NSAIDs, known to have kidney diseases or cardiac disease, active peptic ulcer disease, and pregnancy.

Study groups in NCT06985134
Study group	Role	What they receive
Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Sp	Experimental	Not described Receives: Drug: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study from Bangladesh

What is being measured

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

BASDAI
score of this scale is o to 10. o means no pain and 10 means maximum pain
Measured: 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""

Timeline

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

1 Jan 201731 Dec 2018

First posted22 May 2025
Study start1 Jan 2017
Primary completion31 Dec 2018
Study completion31 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From BangladeshStudies 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06985134
Sponsor's protocol ID: 1638
Status last verified: Jan 2017
First submitted: 13 May 2025
Last updated: 22 May 2025
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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh
ClinicalTrials.gov ID: NCT06985134
Acronym / sponsor ID: 1638
Conditions: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study From Bangladesh, Condition ...Moderate to Severe Axial Spondyloarthopathy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
Study start: 1 Jan 2017 (actual)
Primary completion: 31 Dec 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 22 May 2025 (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.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Sp	Experimental	Drug: Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study from Bangladesh

Who may qualify

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

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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.

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
Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Spondylitis: A Real-World Study from BangladeshThe present study included patients aged >18 years with inflammatory low back pain fulfilling the Modified New York criteria [12], 2014 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 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 who were on DMARDs, allergy to thalidomide, Sulfasalazine, and NSAIDs, known to have kidney diseases or cardiac disease, active peptic ulcer disease, and pregnancy.	Drug	Comparative Efficacy and Safety of Thalidomide and Sulfasalazine in Moderate to Severe Ankylosing Sp

Primary outcome

BASDAI
Time frame: 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""
score of this scale is o to 10. o means no pain and 10 means maximum pain

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Individual participant dataSharing planned: No

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.

ISLAM study director

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?

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 1 inclusion and 1 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 22 May 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

BASDAI (time frame: 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""). 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 NCT06985134.

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 22 May 2025.