Rheumatoid ArthritisPhase 2NCT04834557

Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis

A Phase 2 study testing Digoxin 0.25 mg and Ursodeoxycholic acid (UDCA) 500 mg in people with Rheumatoid Arthritis, run by Tanta University at 1 site in Egypt.

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 purpose of this study is to investigate the potential therapeutic effects of the cardiac glycoside digoxin and 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… 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?: Digoxin 0.25 mg and Ursodeoxycholic acid (UDCA) 500 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteEgypt
Study dates: 1 Nov 2021to 30 Sep 2022
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 digoxin or 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.

Egypt1 site

Menoufia University Hospital
Shibīn al Kawm

Other trials in Egypt

About this study

Official title: Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt

Read the detailed description

This study is a randomized, open-labeled, controlled prospective study to evaluate the potential therapeutic effects of the cardiac glycoside digoxin and 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, Menoufia, Egypt. A total of 90 rheumatoid arthritis patients who will meet the inclusion criteria will be enrolled in this study. The 90 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, 30 rheumatoid arthritis patients who will receive DMARDs + digoxin 25 mg every other day for 24 weeks and the last 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 digoxin and UDCA in the treatment of rheumatoid arthritis.

Conditions: Rheumatoid Arthritis
Being tested: Placebo, Digoxin 0.25 mg, Ursodeoxycholic acid (UDCA) 500 mg
Keywords: Rheumatoid arthritis, Digoxin, Ursodeoxycholic acid, Synovial inflammation, leukocyte infiltration, Autoimmune diseases, Th17 and Treg cells, Synovial hypoxia
Medical subject headings: Arthritis, Rheumatoid, Autoimmune Diseases

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.
Digoxin 0.25 mgDrug
All subjects will receive digoxin administered at 0.25 mg every other day 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 add-on treatment to the current DMARDs treatments for rheumatoid arthritis.

Study groups in NCT04834557
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
Digoxin	Experimental	Participants in this arm will receive digoxin 0.25 mg every other day + DMARDs for 24 weeks. Receives: Drug: Digoxin 0.25 mg
Ursodeoxycholic acid (UDCA)	Experimental	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 from Baseline in Clinical Disease Activity Index (CDAI) Score
To evaluate the effect of the use of digoxin and 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 Index (CDAI) scores. A lower CDAI score from Baseline would mean improvement in disease activity and an increase in CDAI score from Baseline would mean an increase in disease activity or a worsening in disease activity. Scores: 0.0-2.8 = Range for Remission; 2.9-10.0 = Range for Low disease activity; 10.1-22.0 Range for Moderate disease activity; 22.1-76 Range for High disease activity. Total range is from 0-100, with the high scores representing high disease activity.
Measured: Baseline, after 12 weeks, after 24 weeks
Changes in C-Reactive Protein (CRP) Values and Erythrocyte Sedimentation Rates (ESR)
C- reactive Protein (CRP) values and Erythrocyte Sedimentation Rate (ESR) will be made at baseline and after 12 as well as 24 weeks to determine the number of patients whose test result improved or worsened CRP value (normal range <1.0 mg/dl). ESR (normal range 0-28 mm/hr) . If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved.
Measured: Baseline, after 12 weeks, after 24 weeks

Secondary outcomes (2)

Changes from baseline Measurement of IL-17A and HIF-1α at 12 and 24 weeks
Serum IL-17A and HIF-1α levels 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.

1 Nov 202130 Sep 2022

First posted8 Apr 2021
Study start1 Nov 2021
Primary completion18 May 2022
Study completion30 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)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 study is a randomized controlled prospective study
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04834557
Sponsor's protocol ID: Treating Rheumatoid Arthritis
Status last verified: Mar 2023
First submitted: 2 Apr 2021
Last updated: 22 Mar 2023
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 20872595
Neogi 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 20872596
Hua S, Dias TH. Hypoxia-Inducible Factor (HIF) as a Target for Novel Therapies in Rheumatoid Arthritis. Front Pharmacol. 2016 Jun 27;7:184. doi: 10.3389/fphar.2016.00184. eCollection 2016.
PubMed 27445820
Lee 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 28539269
O'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
Saeed H, Mateen S, Moin S, Khan AQ, Owais M. Cardiac glycoside digoxin ameliorates pro-inflammatory cytokines in PBMCs of rheumatoid arthritis patients in vitro. Int Immunopharmacol. 2020 May;82:106331. doi: 10.1016/j.intimp.2020.106331. Epub 2020 Feb 24.
PubMed 32106058
El-Mahdy NA, Tadros MG, El-Masry TA, Binsaleh AY, Alsubaie N, Alrossies A, Abd Elhamid MI, Osman EY, Shalaby HM, Saif DS. Efficacy of the cardiac glycoside digoxin as an adjunct to csDMARDs in rheumatoid arthritis patients: a randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2024 Oct 21;15:1445708. doi: 10.3389/fphar.2024.1445708. eCollection 2024.
PubMed 39498340

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Effect of Digoxin and Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt
ClinicalTrials.gov ID: NCT04834557
Acronym / sponsor ID: Treating Rheumatoid Arthritis
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis, Digoxin, Ursodeoxycholic acid, Synovial inflammation, leukocyte infiltration, Autoimmune diseases, Th17 and Treg cells, Synovial hypoxia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Tanta UniversityUniversity, hospital or other
Study start: 1 Nov 2021 (actual)
Primary completion: 18 May 2022 (actual)
Study completion: 30 Sep 2022 (actual)
First posted: 8 Apr 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This study is a randomized controlled prospective study

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.
Digoxin	Experimental	Drug: Digoxin 0.25 mgParticipants in this arm will receive digoxin 0.25 mg every other day + DMARDs for 24 weeks.
Ursodeoxycholic acid (UDCA)	Experimental	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
Digoxin 0.25 mgAll subjects will receive digoxin administered at 0.25 mg every other day for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.	Drug	Digoxin
Ursodeoxycholic acid (UDCA) 500 mgAll subjects will receive Ursodeoxycholic acid (UDCA) administered at 500 mg/day for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.	Drug	Ursodeoxycholic acid (UDCA)

Primary outcome

Changes from Baseline in Clinical Disease Activity Index (CDAI) Score
Time frame: Baseline, after 12 weeks, after 24 weeks
To evaluate the effect of the use of digoxin and 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 Index (CDAI) scores. A lower CDAI score from Baseline would mean improvement in disease activity and an increase in CDAI score from Baseline would mean an increase in disease activity or a worsening in disease activity. Scores: 0.0-2.8 = Range for Remission; 2.9-10.0 = Range for Low disease activity; 10.1-22.0 Range for Moderate disease activity; 22.1-76 Range for High disease activity. Total range is from 0-100, with the high scores representing high disease activity.
Changes in C-Reactive Protein (CRP) Values and Erythrocyte Sedimentation Rates (ESR)
Time frame: Baseline, after 12 weeks, after 24 weeks
C- reactive Protein (CRP) values and Erythrocyte Sedimentation Rate (ESR) will be made at baseline and after 12 as well as 24 weeks to determine the number of patients whose test result improved or worsened CRP value (normal range <1.0 mg/dl). ESR (normal range 0-28 mm/hr) . If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved.

2 secondary outcomes

Changes from baseline Measurement of IL-17A and HIF-1α 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 22 Mar 2023.
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 27445820Hua S, Dias TH. Hypoxia-Inducible Factor (HIF) as a Target for Novel Therapies in Rheumatoid Arthritis. Front Pharmacol. 2016 Jun 27;7:184. doi: 10.3389/fphar.2016.00184. eCollection 2016.
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.
Background: PubMed 32106058Saeed H, Mateen S, Moin S, Khan AQ, Owais M. Cardiac glycoside digoxin ameliorates pro-inflammatory cytokines in PBMCs of rheumatoid arthritis patients in vitro. Int Immunopharmacol. 2020 May;82:106331. doi: 10.1016/j.intimp.2020.106331. Epub 2020 Feb 24.
Derived from this study: PubMed 39498340El-Mahdy NA, Tadros MG, El-Masry TA, Binsaleh AY, Alsubaie N, Alrossies A, Abd Elhamid MI, Osman EY, Shalaby HM, Saif DS. Efficacy of the cardiac glycoside digoxin as an adjunct to csDMARDs in rheumatoid arthritis patients: a randomized, double-blind, placebo-controlled trial. Front Pharmacol. 2024 Oct 21;15:1445708. doi: 10.3389/fphar.2024.1445708. eCollection 2024.

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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, PHD 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 Digoxin 0.25 mg and 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 22 Mar 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 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 from Baseline in Clinical Disease Activity Index (CDAI) Score (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 NCT04834557, which also lists 7 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 22 Mar 2023.