Rheumatoid ArthritisPhase 2NCT05447520
Montelukast Use in Rheumatoid Arthritis
A Phase 2 study testing Montelukast and Conventional DMARDs in people with Rheumatoid Arthritis, run by Noha Mansour at 1 site in Egypt.
Trial summary
Montelukast is widely used in patients with asthma. Several preclinical data suggest that it could be repositioned as novel strategy for managing rheumatic patients by decreasing inflammatory mediators. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Montelukast and Conventional DMARDs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2021to 30 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients ages ≥ 18 years old.
- Patients diagnosed with RA according to American College of Rheumatology/European league Against Rheumatism (ACR/ EULAR) 2010 criteria (25) presented with disease activity score-28 based on C-reactive protein (CRP) levels (DAS-28-CRP) >3.2.
- Patient received stable regimen of one or more csDMARDs for at least the past 3 months.
Who cannot join
- Patient taking biological DMARDs.
- Known hypersensitivity to montelukast.
- Patients receive montelukast for any other indications.
- Patients with impaired liver functions (liver transaminases level ≥ three times upper normal limits).
- Patients with impaired kidney (estimated glomerular filtration rate (eGFR) < 30 ml/min).
- Pregnancy and lactation.
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- Patients with active or severe infections.
- Patients with other inflammatory or autoimmune diseases and malignancies.
- Patients with any psychiatric disorder.
- Patients taking IV, IM, orally (dose > 10 mg daily) or intra articular corticosteroides,
- Smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Montelukast in Rheumatoid Arthritis Patients
Montelukast is widely used in patients with asthma. Several preclinical data suggest that it could be repositioned as novel strategy for managing rheumatic patients by decreasing inflammatory mediators.
Considering the probable enhanced antiarthritic effects of montelukast; it could be hypothesized that its adjuvant use might improve treatment outcomes in rheumatic patients who remain poorly controlled despite initial optimal guidelines directed medical treatment. Therefore, this study aims to evaluate the potential added benefits of montelukast use in conjunction with csDMARDs in RA patients with moderate and high disease activity.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Montelukast, Placebo, Conventional DMARDs
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Montelukast 10 mg oral tablet once daily for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2
PlaceboDrug
Oral tablet once daily
Conventional DMARDsDrug
methotrexate, leflunomide, hydroxychloroquine or sulfasalazine
| Study group | Role | What they receive |
|---|---|---|
| Montelukast Group | Experimental | Patients will receive conventional DMARDs plus montelukast 10 mg tablet once daily for 16 weeks. Receives: Drug: Montelukast; Drug: Conventional DMARDs |
| Control Group | Placebo comparator | Patients will receive conventional DMARDs plus placebo tablet daily for 16 weeks Receives: Drug: Placebo; Drug: Conventional DMARDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity score in 28 joints (DAS-28)
Scale assessing severity of rheumatoid arthritis based on number of tender , swollen joints , CRP levels ,and patient self-assessment of his condition (global health assessment) . Whereas "28" describes the number of different joints including in the measurement :proximal interphalangeal joints (10 joints),metacarpophalangeal joints (10),wrists (2),elbows (2),shoulders (2),knees (2).
A DAS-28 value < 2.6 corresponds to remission,value between 2.6 and 3.2 corresponds to a low disease activity, value between 3.2 and 5.1 corresponds to a moderate disease activity, and DAS28 value >5.1 corresponds to a high disease activity.
Measured: 16 weeks
Secondary outcomes (1)
Assessment of patient's QOL using Health Assessment Questionnaire Disability index (HAQ-DI)
It comprises eight categories assessing the ability of patients to perform activities of daily living. Each category includes two or three questions scored from 0 (without any difficulty) to 3 (unable to do).
- The score of each category is the highest score among the scores of the included questions.
- If an aid or assistance device is used or if help is required from another individual, then the minimum score for that section is 2.
- The final score is calculated by summation of the scores for various categories divided by the number of categories.
- Resulting in a score from 0 to 3.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start15 Dec 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noha Mansour
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Mansour, Mansoura University
- Investigators
- Noha Mansour, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447520
- Sponsor's protocol ID
- 2021-376
- Status last verified
- Feb 2024
- First submitted
- 1 Jul 2022
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Montelukast in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT05447520
- Acronym / sponsor ID
- 2021-376
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Noha MansourUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 7 Jul 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.
Montelukast is widely used in patients with asthma. Several preclinical data suggest that it could be repositioned as novel strategy for managing rheumatic patients by decreasing inflammatory mediators.
Considering the probable enhanced antiarthritic effects of montelukast; it could be hypothesized that its adjuvant use might improve treatment outcomes in rheumatic patients who remain poorly controlled despite initial optimal guidelines directed medical treatment. Therefore, this study aims to evaluate the potential added benefits of montelukast use in conjunction with csDMARDs in RA patients with moderate and high disease activity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast Group | Experimental | Drug: Montelukast, Drug: Conventional DMARDsPatients will receive conventional DMARDs plus montelukast 10 mg tablet once daily for 16 weeks. |
| Control Group | Placebo comparator | Drug: Placebo, Drug: Conventional DMARDsPatients will receive conventional DMARDs plus placebo tablet daily for 16 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients ages ≥ 18 years old.
- Patients diagnosed with RA according to American College of Rheumatology/European league Against Rheumatism (ACR/ EULAR) 2010 criteria (25) presented with disease activity score-28 based on C-reactive protein (CRP) levels (DAS-28-CRP) >3.2.
- Patient received stable regimen of one or more csDMARDs for at least the past 3 months.
Key exclusion criteria (11 listed)
- Patient taking biological DMARDs.
- Known hypersensitivity to montelukast.
- Patients receive montelukast for any other indications.
- Patients with impaired liver functions (liver transaminases level ≥ three times upper normal limits).
- Patients with impaired kidney (estimated glomerular filtration rate (eGFR) < 30 ml/min).
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 |
|---|---|---|
| MontelukastMontelukast 10 mg oral tablet once daily for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2 | Drug | Montelukast Group |
| PlaceboOral tablet once daily | Drug | Control Group |
| Conventional DMARDsmethotrexate, leflunomide, hydroxychloroquine or sulfasalazine | Drug | Control Group, Montelukast Group |
Primary outcome
Disease activity score in 28 joints (DAS-28)
Time frame: 16 weeks
Scale assessing severity of rheumatoid arthritis based on number of tender , swollen joints , CRP levels ,and patient self-assessment of his condition (global health assessment) . Whereas "28" describes the number of different joints including in the measurement :proximal interphalangeal joints (10 joints),metacarpophalangeal joints (10),wrists (2),elbows (2),shoulders (2),knees (2). A DAS-28 value < 2.6 corresponds to remission,value between 2.6 and 3.2 corresponds to a low disease activity, value between 3.2 and 5.1 corresponds to a moderate disease activity, and DAS28 value >5.1 corresponds to a high disease activity.
1 secondary outcome
Assessment of patient's QOL using Health Assessment Questionnaire Disability index (HAQ-DI)
Time frame: 16 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 13 Feb 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.
Noha Mansour principal investigator
Mansoura 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 Montelukast and Conventional DMARDs in people with Rheumatoid Arthritis, run by Noha Mansour 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 3 inclusion and 11 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 13 Feb 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?
Disease activity score in 28 joints (DAS-28) (time frame: 16 weeks). 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 13 Feb 2024.