Trial · NCT02713256
A Study to Evaluate the Safety and Effect of CFZ533 on Patients With Graves' Disease
NCT02713256, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2018-05-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Effect of CFZ533 on Patients With Graves' Disease. Trials, record NCT02713256. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02713256
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Effect of CFZ533 on Patients With Graves' Disease
- NCT number
- NCT02713256
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Graves' Disease
- Interventions
- CFZ533
- First posted
- 2016-03-18
- Last updated
- 2021-01-05
- Other registries' IDs
- eudract:2015-005564-41
- Results first posted
- 2018-05-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Whose Thyroid Stimulating Hormone (TSH) Levels Normalize After 12 Week Treatment | 12 week (DAY 85) | Normalization of TSH is defined as TSH level greater than 0.35 mU/L after 12 week treatment (Day 85) |
| Primary | Percentage of Participants Whose Total Triiodothyronine (Total T3) Levels Decrease After 12 Week Treatment | 12 week (DAY 85) | Percentage of participants whose total triiodothyronine (total T3) levels decrease after 12 week treatment. A decrease is when total T3 level is below Upper limit of normal (ULN) ≤ 2.79 nmol/L |
| Primary | Percentage of Participants Whose Free Thyroxine (Free T4) Levels Decrease After 12 Week Treatment | 12 week (DAY 85) | Percentage of participants whose free thyroxine (free T4) levels decrease after 12 weeks of treatment (DAY85). A decrease is when free T4 level is below Upper limit of normal (ULN) ≤ 22.7 pmol/L) |
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 | Percentage of Participants Whose Thyroid Stimulating Hormone (TSH) Levels Normalize After 12 Week Treatment | 12 week (DAY 85) | Pharmacodynamic (PD) Analysis Set- all patients in the study was included in this analysis set. Patients who discontinue before 4 weeks of treatment for any reason are not counted for the calculation of responders. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Whose Total Triiodothyronine (Total T3) Levels Decrease After 12 Week Treatment | 12 week (DAY 85) | Pharmacodynamic (PD) Analysis Set- all patients in the study was included in this analysis set. Patients who discontinue before 4 weeks of treatment for any reason are not counted for the calculation of responders. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Whose Free Thyroxine (Free T4) Levels Decrease After 12 Week Treatment | 12 week (DAY 85) | Pharmacodynamic (PD) Analysis Set- all patients in the study was included in this analysis set. Patients who discontinue before 4 weeks of treatment for any reason are not counted for the calculation of responders. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Whose Thyroid Stimulating Hormone (TSH) Levels Normalize After 12 Week Treatment | CFZ533 10 mg/kg | 0 | percentage of participants | ||
| Percentage of Participants Whose Total Triiodothyronine (Total T3) Levels Decrease After 12 Week Treatment | CFZ533 10 mg/kg | 38.5 | percentage of participants | ||
| Percentage of Participants Whose Free Thyroxine (Free T4) Levels Decrease After 12 Week Treatment | CFZ533 10 mg/kg | 30.8 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CFZ533 10 mg/kg | 15 | |
| Overall Study | COMPLETED | CFZ533 10 mg/kg | 15 | |
| Overall Study | NOT COMPLETED | CFZ533 10 mg/kg | 0 |
Source ClinicalTrials.gov
Adverse events27
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 | PALPITATIONS | Cardiac disorders | CFZ533 10 mg/kg | 1 | 15 | |
| other | VERTIGO | Ear and labyrinth disorders | CFZ533 10 mg/kg | 1 | 15 | |
| other | CONSTIPATION | Gastrointestinal disorders | CFZ533 10 mg/kg | 1 | 15 | |
| other | DIARRHOEA | Gastrointestinal disorders | CFZ533 10 mg/kg | 1 | 15 | |
| other | DRY MOUTH | Gastrointestinal disorders | CFZ533 10 mg/kg | 1 | 15 | |
| other | NAUSEA | Gastrointestinal disorders | CFZ533 10 mg/kg | 2 | 15 | |
| other | VOMITING | Gastrointestinal disorders | CFZ533 10 mg/kg | 1 | 15 | |
| other | FATIGUE | General disorders | CFZ533 10 mg/kg | 2 | 15 | |
| other | CYSTITIS | Infections and infestations | CFZ533 10 mg/kg | 3 | 15 | |
| other | SKIN INFECTION | Infections and infestations | CFZ533 10 mg/kg | 1 | 15 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CFZ533 10 mg/kg | 0 | 15 |
| Total, other adverse events | CFZ533 10 mg/kg | 12 | 15 |
| Total, serious adverse events | CFZ533 10 mg/kg | 1 | 15 |
Source ClinicalTrials.gov
Papers2
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02713256
GET https://conductscience.org/api/trials/v1/NCT02713256/events?page=2