Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients (NCT03002038) | Clinical Trial Compass
CompletedPhase 2/3
Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients
Iran86 participantsStarted 2015-09
Plain-language summary
The purpose of this study is to compare annual relapse rate, expanded disability status scale, and side effects of azathioprine and rituximab in patients with neuromyelitis optica spectrum disorder during a one year follow up through a randomized clinical trial.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of neuromyelitis optica spectrum disorder based on the recent guidelines in 2015
* Expanded disability status scale between 0 and 7
* Age between 18 and 50 years old
Exclusion Criteria:
* Pregnancy or lactation during the study
* Deciding to leave the study by patient
* Lack of consent to enter the study
* Lack of cooperation for follow up
* Severe side effect of the medication
* Treatment with other immunosuppressant medications (including but not limited to cyclophosphamide, mycophenolate mofetil, methotrexate, others) within two months before intervention
* Taking any other immunosuppressant or other type of medication (including herbal drugs) without permission of the physician during the study.
* Presence of other autoimmune disease (including but not limited to Behcet disease, systemic lupus erythematosus, rheumatoid arthritis, and others)
* Presence of liver disorders
* Presence of hematologic disorders
* Presence of heart failure
* Receipt of a live vaccine within 4 weeks prior to intervention
* Previous treatment with Azathioporine or Rituximab
* History of HIV, hepatitis B, or hepatitis C
* Ongoing daily steroid use
* History of severe allergic or anaphylactic reaction to monoclonal antibodies
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.