Rheumatoid ArthritisPhase 2NCT05973370
Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis
A Phase 2 study testing Ursodeoxycholic acid (UDCA) 500 mg in people with Rheumatoid Arthritis, run by Tanta University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate the potential therapeutic effects of the secondary bile acid ursodeoxycholic acid (UDCA) on synovial inflammation and disease activity when administered as add-on treatments to the current DMARDs treatment for rheumatoid arthritis patients with variant disease activity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Ursodeoxycholic acid (UDCA) 500 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 30 May 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with rheumatoid arthritis according to the ACR/EULAR 2010 criteria.
- Having active rheumatoid arthritis disease activity (the 28-joint disease activity score [DAS28] according to the CRP formula > 2.6).
- Aged between 18 and 80 years.
- With clear consciousness and able to cooperate with this study.
- Personal willingness and ability to comply with the study follow-up schedule and other requirements of the study protocol.
- Both male and female will be included
- All patients receiving non-biological drugs will be also included.
- Sign an informed consent for the clinical study.
Who cannot join
- Pregnant or planning to be pregnant and breast-feeding women
- Patients suffering from any chronic diseases
- Patients with other autoimmune diseases, such as systemic lupus erythematosus, Sjogren's syndrome and mixed connective tissue disease.
- Patients who have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
- Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).
- Patients with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
Show all 19Show fewer
- Patients treated with biological therapy such as TNF-α or IL-1β antagonists.
- Patients with infectious or inflammatory diseases, endocrine disorders, any past or current psychiatric or neurological diseases.
- Patients with cardiovascular diseases such as arrhythmias and acute myocardial infarction.
- Patients with electrolyte disturbances (such as hypokalemia, hypomagnesemia, and hypercalcemia) could potentially elevate the risk of digoxin toxicity.
- Patients with clinically significant hepatic and renal dysfunction or impairment.
- Alcohol abuse
- Patients with evidence of viral (HBV or HCV), autoimmune hepatitis, and decompensated liver disease.
- Patients with cancer currently diagnosed or in medical history, if no recovery was achieved.
- Patients who are allergic to Ursodeoxycholic acid (UDCA)
- Patients who are unconscious and unable to complete the study.
- Patients with acute inflammation of the gall bladder or the biliary tract, frequent episodes of biliary colic, and impaired contractility of the gall bladder, will be excluded.
- Patients with cholestasis, primary biliary cirrhosis, or biliary obstruction will also be excluded.
- Patients who have received an organ transplant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt
The purpose of this study is to investigate the potential therapeutic effects of the secondary bile acid ursodeoxycholic acid (UDCA) on synovial inflammation and disease activity when administered as add-on treatments to the current DMARDs treatment for rheumatoid arthritis patients with variant disease activity.
Read the detailed description
This study is a randomized, open-labeled, controlled prospective study to evaluate the potential therapeutic effects of the secondary bile acid ursodeoxycholic acid (UDCA) on synovial inflammation and disease activity when administered as add-on treatments to the current DMARDs treatments for rheumatoid arthritis patients with variant disease activity. The study population will be rheumatoid arthritis patients attending the Physical Medicine, Rheumatology, and Rehabilitation Department at Menoufia University Hospital in Menoufia, Egypt. A total of 60 rheumatoid arthritis patients who met the inclusion criteria will be enrolled in this study. The 60 participants will be divided into 30 rheumatoid arthritis patients who will receive placebo + the current DMARDs treatments of rheumatoid arthritis for 24 weeks and serve as the control group, and 30 rheumatoid arthritis patients who will receive DMARDs + ursodeoxycholic acid (UDCA) 500 mg/day for 24 weeks. Clinical examinations and laboratory parameters will be performed and measured at the beginning of the study, 12 weeks and 24 weeks after randomization to evaluate the efficacy of UDCA in the treatment of rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Placebo, Ursodeoxycholic acid (UDCA) 500 mg
- Keywords
- Rheumatoid arthritis, Ursodeoxycholic acid, Synovial inflammation, Th17 cells, Synovial hypoxia
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo will be administered to the control group for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
Ursodeoxycholic acid (UDCA) 500 mgDrug
All subjects will receive Ursodeoxycholic acid (UDCA) administered at 500 mg/day for 24 weeks as an addon treatment to the current DMARDs treatments for rheumatoid arthritis.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants in this arm will receive Placebo with the current DMARDs treatments for rheumatoid arthritis for 24 weeks. Receives: Drug: Placebo |
| Ursodeoxycholic acid (UDCA) | Active comparator | Participants in this arm will receive ursodeoxycholic acid (UDCA) 500 mg/day + DMARDs for 24 weeks. Receives: Drug: Ursodeoxycholic acid (UDCA) 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ACR20 response criteria
The American College of Rheumatology (ACR) response criteria (ACR20) for rheumatoid arthritis (RA) has been widely adopted as measures of medication efficacy in clinical trials. The ACR20 response has been the preferred endpoint for clinical trials because it is the response shown to discriminate optimally between active treatment and placebo while identifying a few placebo-treated patients as improved.
Measured: Baseline, after 12 weeks, after 24 weeks
Changes from Baseline in DAS28-CRP activity Score
To evaluate the effect of the use of UDCA as an add-on therapy in patients with rheumatoid arthritis by evaluating the change from baseline in the clinical findings as measured by Clinical Disease activity score 28 (DAS28-CRP) scores. A lower DAS28-CRP score from Baseline would mean improvement in disease activity and an increase in DAS28-CRP score from Baseline would mean an increase in disease activity or a worsening in disease activity.
Measured: Baseline, after 12 weeks, after 24 weeks
Secondary outcomes (4)
Changes in ACR50 and ACR70 response criteria
The American College of Rheumatology (ACR) response criteria (ACR50 and 70) for rheumatoid arthritis (RA) have been widely adopted as measures of medication efficacy in clinical trials. The ACR50 and ACR70 responses have been the preferred endpoints for clinical trials because their responses have been shown to discriminate optimally between active treatment and placebo while identifying a few placebo-treated patients as improved.
Measured: Baseline, after 12 weeks, after 24 weeks
Changes in EULAR response criteria
The European League Against Rheumatism (EULAR) response criteria for rheumatoid arthritis (RA) has been widely adopted as a measure of medication efficacy in clinical trials.
Measured: Baseline, after 12 weeks, after 24 weeks
Changes from baseline Measurement of inflammatory markers (IL-17A, IL-23, HIF-1α, VEGF) at 12 and 24 weeks
Serum IL-17A, IL-23, VEGF and HIF-1α levels (pg/ml) will be measured by means of the human enzyme-linked immunosorbent assay (ELISA) technique according to the manufacturer's protocol.
Measured: Baseline, after 12 weeks, after 24 weeks
Numbers of participants with treatment-related adverse events
The adverse events in each group will be observed and documented during the whole procedure to show the safety of the treatment.
Measured: Baseline, after 12 weeks, after 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 May 2023
- Primary completion30 Nov 2023
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Tanta 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, prospective, placebo-controlled study that will be conducted on 60 patients who fulfill the selection criteria and will be classified randomly into two groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam George Tadros Bolous, Tanta University
- Investigators
- Nageh Ahmed El-Mahdy, Professor, Study chair, Professor of Pharmacology and Toxicology Faculty of Pharmacy, Tanta UniversityMedhat Ismail Abdel Hamid, Professor, Study chair, Professor of Pharmacology and Toxicology Faculty of Medicine, Al-Azhar UniversityDalia Salah Seif, Associate Professor, Study director, Associate Professor of Physical Medicine, Rheumatology and Rehabilitation Faculty of Medicine, Menoufyia UniversityEnass Yousef Osman, PHD, Study director, Lecturer of Pharmacology and toxicology, Faculty of Pharmacy, Tanta UniversityMariam George Tadros Bolous, Master, Principal investigator, Assistant Lecturer of Clinical pharmacy, Faculty of Pharmacy, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973370
- Sponsor's protocol ID
- Effect of UDCA on Rheumatoid
- Status last verified
- May 2024
- First submitted
- 23 Jul 2023
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
PubMed 20872595Neogi T, Aletaha D, Silman AJ, Naden RL, Felson DT, Aggarwal R, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Khanna D, Kvien TK, Laing T, Liao K, Mease P, Menard HA, Moreland LW, Nair R, Pincus T, Ringold S, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G; American College of Rheumatology; European League Against Rheumatism. The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis: Phase 2 methodological report. Arthritis Rheum. 2010 Sep;62(9):2582-91. doi: 10.1002/art.27580.
PubMed 20872596Lee EJ, Kwon JE, Park MJ, Jung KA, Kim DS, Kim EK, Lee SH, Choi JY, Park SH, Cho ML. Ursodeoxycholic acid attenuates experimental autoimmune arthritis by targeting Th17 and inducing pAMPK and transcriptional corepressor SMILE. Immunol Lett. 2017 Aug;188:1-8. doi: 10.1016/j.imlet.2017.05.011. Epub 2017 May 21.
PubMed 28539269O'Dwyer AM, Lajczak NK, Keyes JA, Ward JB, Greene CM, Keely SJ. Ursodeoxycholic acid inhibits TNFalpha-induced IL-8 release from monocytes. Am J Physiol Gastrointest Liver Physiol. 2016 Aug 1;311(2):G334-41. doi: 10.1152/ajpgi.00406.2015. Epub 2016 Jun 23.
PubMed 27340129
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt
- ClinicalTrials.gov ID
- NCT05973370
- Acronym / sponsor ID
- Effect of UDCA on Rheumatoid
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Ursodeoxycholic acid, Synovial inflammation, Th17 cells, Synovial hypoxia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 2 Aug 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.
The purpose of this study is to investigate the potential therapeutic effects of the secondary bile acid ursodeoxycholic acid (UDCA) on synovial inflammation and disease activity when administered as add-on treatments to the current DMARDs treatment for rheumatoid arthritis patients with variant disease activity.
Detailed description
This study is a randomized, open-labeled, controlled prospective study to evaluate the potential therapeutic effects of the secondary bile acid ursodeoxycholic acid (UDCA) on synovial inflammation and disease activity when administered as add-on treatments to the current DMARDs treatments for rheumatoid arthritis patients with variant disease activity. The study population will be rheumatoid arthritis patients attending the Physical Medicine, Rheumatology, and Rehabilitation Department at Menoufia University Hospital in Menoufia, Egypt. A total of 60 rheumatoid arthritis patients who met the inclusion criteria will be enrolled in this study. The 60 participants will be divided into 30 rheumatoid arthritis patients who will receive placebo + the current DMARDs treatments of rheumatoid arthritis for 24 weeks and serve as the control group, and 30 rheumatoid arthritis patients who will receive DMARDs + ursodeoxycholic acid (UDCA) 500 mg/day for 24 weeks. Clinical examinations and laboratory parameters will be performed and measured at the beginning of the study, 12 weeks and 24 weeks after randomization to evaluate the efficacy of UDCA in the treatment of rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, prospective, placebo-controlled study that will be conducted on 60 patients who fulfill the selection criteria and will be classified randomly into two groups.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: PlaceboParticipants in this arm will receive Placebo with the current DMARDs treatments for rheumatoid arthritis for 24 weeks. |
| Ursodeoxycholic acid (UDCA) | Active comparator | Drug: Ursodeoxycholic acid (UDCA) 500 mgParticipants in this arm will receive ursodeoxycholic acid (UDCA) 500 mg/day + DMARDs for 24 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with rheumatoid arthritis according to the ACR/EULAR 2010 criteria.
- Having active rheumatoid arthritis disease activity (the 28-joint disease activity score [DAS28] according to the CRP formula > 2.6).
- Aged between 18 and 80 years.
- With clear consciousness and able to cooperate with this study.
- Personal willingness and ability to comply with the study follow-up schedule and other requirements of the study protocol.
Key exclusion criteria (19 listed)
- Pregnant or planning to be pregnant and breast-feeding women
- Patients suffering from any chronic diseases
- Patients with other autoimmune diseases, such as systemic lupus erythematosus, Sjogren's syndrome and mixed connective tissue disease.
- Patients who have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
- Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).
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 |
|---|---|---|
| PlaceboPlacebo will be administered to the control group for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis. | Drug | Control |
| Ursodeoxycholic acid (UDCA) 500 mgAll subjects will receive Ursodeoxycholic acid (UDCA) administered at 500 mg/day for 24 weeks as an addon treatment to the current DMARDs treatments for rheumatoid arthritis. | Drug | Ursodeoxycholic acid (UDCA) |
Primary outcome
Changes in ACR20 response criteria
Time frame: Baseline, after 12 weeks, after 24 weeks
The American College of Rheumatology (ACR) response criteria (ACR20) for rheumatoid arthritis (RA) has been widely adopted as measures of medication efficacy in clinical trials. The ACR20 response has been the preferred endpoint for clinical trials because it is the response shown to discriminate optimally between active treatment and placebo while identifying a few placebo-treated patients as improved.
Changes from Baseline in DAS28-CRP activity Score
Time frame: Baseline, after 12 weeks, after 24 weeks
To evaluate the effect of the use of UDCA as an add-on therapy in patients with rheumatoid arthritis by evaluating the change from baseline in the clinical findings as measured by Clinical Disease activity score 28 (DAS28-CRP) scores. A lower DAS28-CRP score from Baseline would mean improvement in disease activity and an increase in DAS28-CRP score from Baseline would mean an increase in disease activity or a worsening in disease activity.
4 secondary outcomes
Changes in ACR50 and ACR70 response criteria
Time frame: Baseline, after 12 weeks, after 24 weeks
Changes in EULAR response criteria
Time frame: Baseline, after 12 weeks, after 24 weeks
Changes from baseline Measurement of inflammatory markers (IL-17A, IL-23, HIF-1α, VEGF) at 12 and 24 weeks
Time frame: Baseline, after 12 weeks, after 24 weeks
Numbers of participants with treatment-related adverse events
Time frame: Baseline, after 12 weeks, after 24 weeks
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 3 Jun 2024.
- Background: PubMed 20872595Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
- Background: PubMed 20872596Neogi T, Aletaha D, Silman AJ, Naden RL, Felson DT, Aggarwal R, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Khanna D, Kvien TK, Laing T, Liao K, Mease P, Menard HA, Moreland LW, Nair R, Pincus T, Ringold S, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G; American College of Rheumatology; European League Against Rheumatism. The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis: Phase 2 methodological report. Arthritis Rheum. 2010 Sep;62(9):2582-91. doi: 10.1002/art.27580.
- Background: PubMed 28539269Lee EJ, Kwon JE, Park MJ, Jung KA, Kim DS, Kim EK, Lee SH, Choi JY, Park SH, Cho ML. Ursodeoxycholic acid attenuates experimental autoimmune arthritis by targeting Th17 and inducing pAMPK and transcriptional corepressor SMILE. Immunol Lett. 2017 Aug;188:1-8. doi: 10.1016/j.imlet.2017.05.011. Epub 2017 May 21.
- Background: PubMed 27340129O'Dwyer AM, Lajczak NK, Keyes JA, Ward JB, Greene CM, Keely SJ. Ursodeoxycholic acid inhibits TNFalpha-induced IL-8 release from monocytes. Am J Physiol Gastrointest Liver Physiol. 2016 Aug 1;311(2):G334-41. doi: 10.1152/ajpgi.00406.2015. Epub 2016 Jun 23.
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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.
Nageh Ahmed El-Mahdy, Professor study chair
Professor of Pharmacology and Toxicology Faculty of Pharmacy, Tanta University
Medhat Ismail Abdel Hamid, Professor study chair
Professor of Pharmacology and Toxicology Faculty of Medicine, Al-Azhar University
Dalia Salah Seif, Associate Professor study director
Associate Professor of Physical Medicine, Rheumatology and Rehabilitation Faculty of Medicine, Menoufyia University
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 Ursodeoxycholic acid (UDCA) 500 mg in people with Rheumatoid Arthritis, run by Tanta University at 1 site in Egypt.
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 8 inclusion and 19 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 3 Jun 2024. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
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?
Changes in ACR20 response criteria (time frame: Baseline, after 12 weeks, after 24 weeks). The study lists 2 primary outcomes in all. 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 NCT05973370, which also lists 4 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 3 Jun 2024.