Ankylosing SpondylitisPhase 4NCT05527444
The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients
A Phase 4 study testing Secukinumab 150 mg/ml, Adalimumab Ab and NSAID in people with Ankylosing Spondylitis, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the clinical efficacy, safety and immunological changes of secukinumab(sec) compared to adalimumab(ada) in patients with active ankylosing spondylitis(AS), who previously have an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or bioagents. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Secukinumab 150 mg/ml, Adalimumab Ab and NSAID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2022to 31 Dec 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet modified New York 1984 criteria for ankylosing spondylitis；
- Age ≥18 years and ≤ 65 years；
- ASDAS ≥ 1.3；
- Concomitant drugs: use stable doses of NSAIDs alone for at least 4 weeks before the baseline period, stop other oral drugs such as methotrexate (MTX), sulfasalazine (SASP), glucocorticoids. Glucocorticoids can be injected locally after 12 weeks, NSAIDs keep stable for 12 weeks；
- Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent.
Who cannot join
- Patients with severe infections, tumors and damage to vital organs:
- Platelet counts(PLT) <80 x 10^9 / L, or white blood cell (WBC) <3 x10^9 / L;
- Propionate acid aminotransferase (ALT) or aspartate aminotransferase(AST) is two times higher than the upper limit of normal;
- Renal insufficiency: serum Cr ≥ 176 umol / L;
- Pregnant or nursing women (breastfeeding) ;
- Patients has a history of malignancy (cure time in less than 5 years);
Show all 12Show fewer
- Patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction;
- Patients with current or previous Crohn's disease;
- Patients with current ulcerative colitis requiring immunosuppressive therapy;
- Any active infection Active viral hepatitis includes hepatitis B virus (HBV), hepatitis C virus (HCV), human papillomavirus (HPV). Active infections include small intestine herpes zoster virus (VZV), human immunodeficiency virus (HIV), syphilis or tuberculosis;
- Patients who have received live vaccines within 4 weeks before randomization or plan to receive live vaccines during the trial;
- Patients who had inadequate response, intolerance or contraindication for both adalimumab and secukinumab.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the clinical efficacy, safety and immunological changes of secukinumab(sec) compared to adalimumab(ada) in patients with active ankylosing spondylitis(AS), who previously have an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or bioagents.
Read the detailed description
Biologic naïve participants will be randomly assigned in a 2:1 ratio to receive secukinumab or adalimumab for 24 weeks. Participants with a history of an inadequate response to secukinumab or adalimumab, will be treated with the alternative drug (adalimumab or secukinumab) for 24 weeks. The disease activity and index of inmunology will be evaluated at weeks 0, 12, 24 up to 96 weeks.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Secukinumab 150 mg/ml, Adalimumab Ab, NSAID, Thalidomide Pill
- Keywords
- secukinumab, adalimumab
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secukinumab 150 mg/mlDrug
Also called Secukinumab
Secukinumab 150 mg will be administered at Baseline, Week 1, 2, 3, 4, 6, 8 followed by dosing every 4 weeks until Week 24
Adalimumab AbDrug
Also called Adalimumab
adalimumab biosimilar 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 24
NSAIDDrug
stable dose
Thalidomide PillDrug
If patients have inadequate response to bioagents, thalidomide 50 mg will be administered at 12 week followed by dosing everyday until Week 24.
| Study group | Role | What they receive |
|---|---|---|
| Randomized-SEC group | Experimental | actived AS patients naïve to ADA and SEC Receives: Drug: Secukinumab 150 mg/ml; Drug: NSAID; Drug: Thalidomide Pill |
| Randomized-ADA group | Experimental | actived AS patients naïve to ADA and SEC Receives: Drug: Adalimumab Ab; Drug: NSAID; Drug: Thalidomide Pill |
| Non-Randomized-SEC group | Experimental | AS patients who previously had inadequate response to ADA Receives: Drug: Secukinumab 150 mg/ml; Drug: NSAID; Drug: Thalidomide Pill |
| Non-Randomized-ADA group | Experimental | AS patients who previously had inadequate response to SEC Receives: Drug: Adalimumab Ab; Drug: NSAID; Drug: Thalidomide Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
Measured: Baseline and Week 12
Secondary outcomes (12)
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 20 Response
ASAS 20 response was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 units [on a scale of 0 to 10]) in the remaining domain:
Patient's global assessment of disease activity, measured on a NRS from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the BASFI which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related BASDAI NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Measured: Baseline and Week 12, 24, 96
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
Measured: Baseline and Week 24, 96
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response
ASAS 40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Measured: Baseline and Week 12, 24, 96
Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.
A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.
Measured: Baseline and Week 12, 24, 96
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.
Measured: Baseline and Week 12, 24, 96
Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin])
The BASMI is a composite score based on 5 direct measurements of spinal mobility:
cervical rotation (measured in degrees), tragus to wall distance (in centimeters [cm]) lumbar side flexion (in cm), lumbar flexion (modified Schober's) (in cm) and intermalleolar distance (in cm). Each measurement is converted to a linear score between 0 and 10. The total BASMI score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.
Measured: Baseline and Week 12, 24, 96
Change From Baseline in ASAS Health Index (HI)
The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.
Measured: Baseline and Week 12, 24, 96
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Change from Baseline in ESR, ESR will be measured with blood samples.
Measured: Baseline and Week 12, 24, 96
Change From Baseline in C-reactive Protein (CRP)
Change from Baseline in C-reactive Protein (CRP), a component index of ASDAS will be measured with blood samples.
Measured: Baseline and Week 12, 24, 96
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses.
Measured: Baseline and Week 12, 24, 96
modiifed stoke ankylosing spondylitis spine score (mSASSS)
modiifed stoke ankylosing spondylitis spine score ( range 0-72), a system for grading and evaluating cervical spine, lumbar spine, sacroiliac joint and hip joint by X-ray.
Measured: Baseline and Week 96
Dynamics of T Cell subset
T cell subsets, including cytotoxic T (Tc) cells, helper T (Th) cells
Measured: Baseline and Baseline and Week 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start15 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Shu, Qilu Hospital of Shandong University
- Investigators
- Yang Xiaoyun, Dr., Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527444
- Sponsor's protocol ID
- effecacy of bioagents-AS QiluH
- Status last verified
- Nov 2023
- First submitted
- 6 May 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients
- ClinicalTrials.gov ID
- NCT05527444
- Acronym / sponsor ID
- effecacy of bioagents-AS QiluH
- Conditions
- Ankylosing Spondylitis
- Keywords
- secukinumab, adalimumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Sep 2022 (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 purpose of this study is to evaluate the clinical efficacy, safety and immunological changes of secukinumab(sec) compared to adalimumab(ada) in patients with active ankylosing spondylitis(AS), who previously have an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or bioagents.
Detailed description
Biologic naïve participants will be randomly assigned in a 2:1 ratio to receive secukinumab or adalimumab for 24 weeks. Participants with a history of an inadequate response to secukinumab or adalimumab, will be treated with the alternative drug (adalimumab or secukinumab) for 24 weeks. The disease activity and index of inmunology will be evaluated at weeks 0, 12, 24 up to 96 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Randomized-SEC group | Experimental | Drug: Secukinumab 150 mg/ml, Drug: NSAID, Drug: Thalidomide Pillactived AS patients naïve to ADA and SEC |
| Randomized-ADA group | Experimental | Drug: Adalimumab Ab, Drug: NSAID, Drug: Thalidomide Pillactived AS patients naïve to ADA and SEC |
| Non-Randomized-SEC group | Experimental | Drug: Secukinumab 150 mg/ml, Drug: NSAID, Drug: Thalidomide PillAS patients who previously had inadequate response to ADA |
| Non-Randomized-ADA group | Experimental | Drug: Adalimumab Ab, Drug: NSAID, Drug: Thalidomide PillAS patients who previously had inadequate response to SEC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who meet modified New York 1984 criteria for ankylosing spondylitis；
- Age ≥18 years and ≤ 65 years；
- ASDAS ≥ 1.3；
- Concomitant drugs: use stable doses of NSAIDs alone for at least 4 weeks before the baseline period, stop other oral drugs such as methotrexate (MTX), sulfasalazine (SASP), glucocorticoids. Glucocorticoids can be injected locally after 12 weeks, NSAIDs keep stable for 12 weeks；
- Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent.
Key exclusion criteria (12 listed)
- Patients with severe infections, tumors and damage to vital organs:
- Patients with current or previous Crohn's disease;
- Patients with current ulcerative colitis requiring immunosuppressive therapy;
- Any active infection Active viral hepatitis includes hepatitis B virus (HBV), hepatitis C virus (HCV), human papillomavirus (HPV). Active infections include small intestine herpes zoster virus (VZV), human immunodeficiency virus (HIV), syphilis or tuberculosis;
- Patients who have received live vaccines within 4 weeks before randomization or plan to receive live vaccines during the trial;
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 |
|---|---|---|
| Secukinumab 150 mg/mlAlso: SecukinumabSecukinumab 150 mg will be administered at Baseline, Week 1, 2, 3, 4, 6, 8 followed by dosing every 4 weeks until Week 24 | Drug | Non-Randomized-SEC group, Randomized-SEC group |
| Adalimumab AbAlso: Adalimumabadalimumab biosimilar 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 24 | Drug | Non-Randomized-ADA group, Randomized-ADA group |
| NSAIDstable dose | Drug | Non-Randomized-ADA group, Non-Randomized-SEC group, Randomized-ADA group, Randomized-SEC group |
| Thalidomide PillIf patients have inadequate response to bioagents, thalidomide 50 mg will be administered at 12 week followed by dosing everyday until Week 24. | Drug | Non-Randomized-ADA group, Non-Randomized-SEC group, Randomized-ADA group, Randomized-SEC group |
Primary outcome
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: Baseline and Week 12
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
12 secondary outcomes
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 20 Response
Time frame: Baseline and Week 12, 24, 96
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: Baseline and Week 24, 96
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response
Time frame: Baseline and Week 12, 24, 96
Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
Time frame: Baseline and Week 12, 24, 96
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: Baseline and Week 12, 24, 96
Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin])
Time frame: Baseline and Week 12, 24, 96
Change From Baseline in ASAS Health Index (HI)
Time frame: Baseline and Week 12, 24, 96
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline and Week 12, 24, 96
Change From Baseline in C-reactive Protein (CRP)
Time frame: Baseline and Week 12, 24, 96
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Time frame: Baseline and Week 12, 24, 96
modiifed stoke ankylosing spondylitis spine score (mSASSS)
Time frame: Baseline and Week 96
Dynamics of T Cell subset
Time frame: Baseline and Baseline and Week 12, 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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.
Yang Xiaoyun, Dr. study director
Qilu Hospital of Shandong University
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 Secukinumab 150 mg/ml, Adalimumab Ab and NSAID in people with Ankylosing Spondylitis, run by Qilu Hospital of Shandong University at 1 site in China.
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 12 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 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 China. 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?
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?
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) (time frame: Baseline and Week 12). 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 18 Nov 2023.