Trial · NCT03002038
Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients
NCT03002038, Phase 2, Phase 3, Completed, Isfahan University of Medical Sciences; results first posted 2020-09-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients. Trials, record NCT03002038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03002038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients
- NCT number
- NCT03002038
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 86 participants, actual
- Lead sponsor
- Isfahan University of Medical Sciences
- Conditions
- Neuromyelitis Optica Spectrum Disorder
- Interventions
- Azathioprine, Rituximab
- First posted
- 2016-12-23
- Last updated
- 2020-09-30
- Results first posted
- 2020-09-30
- Limitations and caveats
- lack of blinding, uneven assignment of patients to treatment groups, lack of compliance measures, and short follow-up duration
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annual Relapse Rate | one year | annual relapse rate will be measured in the baseline (according to patients' history in the last year) and after 12 months of intervention. |
| Secondary | Expanded Disability Status Scale | one year | expanded disability status scale will be measured in the baseline and after 12 months of intervention. Expanded disability status scale (EDSS) is a measure of disability for patients. The score ranges from 0-10, with 0 showing normal neurological exam and 10 showing death due to the disabling disease. Thus, higher scores represent more profound levels of disability. |
| Other | Number of Participants With Adverse Drug Reactions | one year | adverse drug reactions will be observed closely and reported during the intervention. We will compare the number of adverse drug reactions in two groups. Also, adverse drug reactions will be described by details in each group. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annual Relapse Rate | one year | Per protocol analysis | Number of relapses | MEAN |
| SECONDARY | Expanded Disability Status Scale | one year | Per protocol analysis | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Adverse Drug Reactions | one year | intention to treat analysis | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annual Relapse Rate | Azathioprine | Baseline | 1 | Standard Deviation 0.38 | Number of relapses |
| Annual Relapse Rate | Rituximab | Baseline | 1.30 | Standard Deviation 0.68 | Number of relapses |
| Annual Relapse Rate | Azathioprine | Outcome | 0.51 | Standard Deviation 0.55 | Number of relapses |
| Annual Relapse Rate | Rituximab | Outcome | 0.21 | Standard Deviation 0.42 | Number of relapses |
| Expanded Disability Status Scale | Azathioprine | Baseline | 2.40 | Standard Deviation 1.24 | score on a scale |
| Expanded Disability Status Scale | Rituximab | Baseline | 3.55 | Standard Deviation 1.95 | score on a scale |
| Expanded Disability Status Scale | Azathioprine | Outcome | 1.95 | Standard Deviation 1.13 | score on a scale |
| Expanded Disability Status Scale | Rituximab | Outcome | 2.56 | Standard Deviation 1.99 | score on a scale |
| Number of Participants With Adverse Drug Reactions | Azathioprine | 3 | Participants | ||
| Number of Participants With Adverse Drug Reactions | Rituximab | 4 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azathioprine | 46 | |
| Overall Study | STARTED | Rituximab | 40 | |
| Overall Study | COMPLETED | Azathioprine | 35 | |
| Overall Study | COMPLETED | Rituximab | 33 | |
| Overall Study | NOT COMPLETED | Azathioprine | 11 | |
| Overall Study | NOT COMPLETED | Rituximab | 7 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mild/moderate allergic reactions | Immune system disorders | Azathioprine | 0 | 46 | 0 |
| other | Mild/moderate allergic reactions | Immune system disorders | Rituximab | 3 | 40 | 3 |
| other | Gastrointestinal intolerance | Gastrointestinal disorders | Azathioprine | 2 | 46 | 2 |
| other | Gastrointestinal intolerance | Gastrointestinal disorders | Rituximab | 0 | 40 | 0 |
| serious | Impaired liver function test | Hepatobiliary disorders | Azathioprine | 1 | 46 | 1 |
| serious | Impaired liver function test | Hepatobiliary disorders | Rituximab | 0 | 40 | 0 |
| serious | Severe allergic reaction | Immune system disorders | Azathioprine | 0 | 46 | 0 |
| serious | Severe allergic reaction | Immune system disorders | Rituximab | 1 | 40 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azathioprine | 0 | 46 |
| Total, all-cause mortality | Rituximab | 0 | 40 |
| Total, other adverse events | Azathioprine | 2 | 46 |
| Total, other adverse events | Rituximab | 3 | 40 |
| Total, serious adverse events | Azathioprine | 1 | 46 |
| Total, serious adverse events | Rituximab | 1 | 40 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Azathioprine vs Rituximab: Number of Participants With Adverse Drug Reactions | Trial comparisons |
| Azathioprine vs Rituximab: deaths from any cause | Trial comparisons |
| Azathioprine vs Rituximab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03002038
GET https://conductscience.org/api/trials/v1/NCT03002038/registered