Interstitial Lung DiseasePhase 2/3NCT05963048
Rituxmab Versus IL-6 in Treating ILD
A Phase 2/3 study testing Rituximab and IL6 inhibitor in people with Interstitial Lung Disease and Scleroderma, run by Assiut University at 1 site in Egypt.
Trial summary
All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Interstitial Lung Disease, Scleroderma
- What is being tested?
- Rituximab and IL6 inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Jun 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- active ILD scleroderma
Who cannot join
- abnormal liver enzymes renal impairment neutropenia <1000 cells/mm3 thrombocytopenia < 50,000 cells/mm3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study About Effect of Rituximab Versus IL-6 Inhibitor in Induction of Remission in Active ILD in Scleroderma Patients
All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test
Read the detailed description
All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test Diffuse infiltrative lung disease (ILD): progressive shortness of breath is the most frequently presentation going to ER pulmonary unit first. It should be considered in case of persistent dry cough or dyspnea, which should be looked for in any patient with SSc. an etiological assessment must be conducted in order not to mistakenly attribute ILD to the SSc.
- Conditions
- Interstitial Lung Disease, Scleroderma
- Being tested
- Rituximab, IL6 inhibitor
- Medical subject headings
- Lung Diseases, Interstitial, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
IV infusion 1000 mg
IL6 inhibitorDrug
Also called Actemra
6 mg/kg I V infusion monthly
| Study group | Role | What they receive |
|---|---|---|
| Rituxmab | Experimental | 1000 mg Rituxmab IV infusion at 1st day then after 15 weeks then after 6 months for 1 year Receives: Drug: Rituximab |
| IL-6 inhibitor | Experimental | 6 mg/kg IV infusion every month not exceed 600 mg for 1 year Receives: Drug: IL6 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced vital capacity
pulmonary function test
Measured: 6 months
Secondary outcomes (2)
computed tomography chest
imaging
Measured: 1 year
modified rodnan skin score
skin score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Dec 2021
- Primary completion30 Dec 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hassanien, Assiut University
- Investigators
- Manal Hassanien, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963048
- Sponsor's protocol ID
- Scleroderma
- Status last verified
- Nov 2023
- First submitted
- 25 Dec 2022
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after finishing
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study About Effect of Rituximab Versus IL-6 Inhibitor in Induction of Remission in Active ILD in Scleroderma Patients
- ClinicalTrials.gov ID
- NCT05963048
- Acronym / sponsor ID
- Scleroderma
- Conditions
- Interstitial Lung Disease, Scleroderma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 27 Jul 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.
All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test
Detailed description
All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test Diffuse infiltrative lung disease (ILD): progressive shortness of breath is the most frequently presentation going to ER pulmonary unit first. It should be considered in case of persistent dry cough or dyspnea, which should be looked for in any patient with SSc. an etiological assessment must be conducted in order not to mistakenly attribute ILD to the SSc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituxmab | Experimental | Drug: Rituximab1000 mg Rituxmab IV infusion at 1st day then after 15 weeks then after 6 months for 1 year |
| IL-6 inhibitor | Experimental | Drug: IL6 inhibitor6 mg/kg IV infusion every month not exceed 600 mg for 1 year |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- active ILD scleroderma
Key exclusion criteria (1 listed)
- abnormal liver enzymes renal impairment neutropenia <1000 cells/mm3 thrombocytopenia < 50,000 cells/mm3
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 |
|---|---|---|
| RituximabAlso: RituxanIV infusion 1000 mg | Drug | Rituxmab |
| IL6 inhibitorAlso: Actemra6 mg/kg I V infusion monthly | Drug | IL-6 inhibitor |
Primary outcome
forced vital capacity
Time frame: 6 months
pulmonary function test
2 secondary outcomes
computed tomography chest
Time frame: 1 year
modified rodnan skin score
Time frame: 6 months
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 15 Nov 2023.
- Individual participant dataSharing planned: Yes. after finishing
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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.
Manal Hassanien, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rituximab and IL6 inhibitor in people with Interstitial Lung Disease and Scleroderma, run by Assiut 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 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced vital capacity (time frame: 6 months). 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 15 Nov 2023.