Trial · NCT02576717
A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
NCT02576717, Phase 3, Completed, Celgene; results first posted 2024-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis. Trials, record NCT02576717. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02576717
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
- NCT number
- NCT02576717
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,494 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Multiple Sclerosis
- Interventions
- RPC1063
- First posted
- 2015-10-15
- Last updated
- 2024-01-30
- Results first posted
- 2024-01-30
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Adverse Events (AEs) | From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months) | An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. |
| Primary | Number of Participants Experiencing Serious Adverse Events (SAEs) | From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months) | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization. |
| Primary | Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months) | An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. |
| Primary | Number of Participants Experiencing Adverse Events (AEs) Leading to Withdrawal | From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months) | An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. |
| Primary | Number of Participants Experiencing Adverse Events (AEs) of Special Interest | From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months) | An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of medicinal product, whether or not considered related to the investigational medicinal product. |
| Primary | Number of Participants With Abnormalities in Blood Absolute Lymphocyte Count (ALC) | From first dose up until last dose of study treatment (up to approximately 82 months) | An absolute lymphocyte count (ALC) is a part of a blood test that measures the number of lymphocytes, a type of white blood cell, in the blood. Lymphocytes help fight infections and diseases. Reductions in ALC levels for participants in this study is expected and is a primary pharmacodynamic effect of RPC1063. LLN = Lower limit of normal |
| Primary | Number of Participants With Abnormalities in White Blood Cell Count (WBC) | From first dose up until last dose of study treatment (up to approximately 82 months) | A white blood cell count is a part of a blood test that measures the number of white blood cells in the blood. White blood cells help fight infections and diseases. LLN = Lower limit of normal |
| Primary | Number of Participants With Abnormalities in Blood Absolute Neutrophil Count (ANC) | From first dose up until last dose of study treatment (up to approximately 82 months) | An absolute neutrophil count is a part of a blood test that measures the number of neutrophils, a type of white blood cell, in the blood. Neutrophils help fight infections and diseases. |
| Primary | Number of Participants With Abnormalities in Specific Liver Function Tests | From first dose up until last dose of study treatment (up to approximately 82 months) | The number of participants with laboratory abnormalities in specific liver tests above ULN by category. ULN = Upper Limit of Normal |
| Primary | Number of Participants With Electrocardiogram (ECG) Result Abnormalities | From first dose to 28-days post last dose (an average of 63 months up to a max of 83 months) | An electrocardiogram (ECG) measures electrical activity of the heart to detect cardiac problems. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Adverse Events (AEs) | From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Serious Adverse Events (SAEs) | From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Adverse Events (AEs) Leading to Withdrawal | From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Experiencing Adverse Events (AEs) of Special Interest | From first dose to 90-days post last dose (an average of 65 months up to a max of 85 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormalities in Blood Absolute Lymphocyte Count (ALC) | From first dose up until last dose of study treatment (up to approximately 82 months) | All treated participants with at least one on treatment ALC assessment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormalities in White Blood Cell Count (WBC) | From first dose up until last dose of study treatment (up to approximately 82 months) | All treated participants with at least one on treatment WBC assessment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormalities in Blood Absolute Neutrophil Count (ANC) | From first dose up until last dose of study treatment (up to approximately 82 months) | All treated participants with at least one on treatment ANC assessment | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormalities in Specific Liver Function Tests | From first dose up until last dose of study treatment (up to approximately 82 months) | All treated participants with at least one on treatment liver function test | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Electrocardiogram (ECG) Result Abnormalities | From first dose to 28-days post last dose (an average of 63 months up to a max of 83 months) | All treated participants with baseline and at least one post baseline ECG assessment | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group742
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) | Parent Treatment Group IFN-B-1a 30 ug | 668 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Parent Treatment Group: RPC1063 0.5 mg | 775 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) | Parent Treatment Group: RPC1063 1.0 mg | 776 | Participants | ||
| Number of Participants Experiencing Serious Adverse Events (SAEs) | Parent Treatment Group IFN-B-1a 30 ug | 108 | Participants | ||
| Number of Participants Experiencing Serious Adverse Events (SAEs) | Parent Treatment Group: RPC1063 0.5 mg | 139 | Participants | ||
| Number of Participants Experiencing Serious Adverse Events (SAEs) | Parent Treatment Group: RPC1063 1.0 mg | 134 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | Parent Treatment Group IFN-B-1a 30 ug | 35 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | Parent Treatment Group: RPC1063 0.5 mg | 35 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | Parent Treatment Group: RPC1063 1.0 mg | 28 | Participants | ||
| Number of Participants Experiencing Adverse Events (AEs) Leading to Withdrawal | Parent Treatment Group IFN-B-1a 30 ug | 32 | Participants |
1 to 10 of 742Source ClinicalTrials.gov
See all 742 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Parent Treatment Group IFN-B-1a 30 ug | 740 | |
| Overall Study | STARTED | Parent Treatment Group: RPC1063 0.5 mg | 875 | |
| Overall Study | STARTED | Parent Treatment Group: RPC1063 1.0 mg | 879 | |
| Overall Study | Transferred From IFN β-1a Parent Group | Parent Treatment Group IFN-B-1a 30 ug | 0 | |
| Overall Study | Transferred From IFN β-1a Parent Group | Parent Treatment Group: RPC1063 0.5 mg | 3 | |
| Overall Study | Transferred From IFN β-1a Parent Group | Parent Treatment Group: RPC1063 1.0 mg | 1 | |
| Overall Study | Transferred From RPC1063 0.5 mg Parent Group | Parent Treatment Group IFN-B-1a 30 ug | 0 | |
| Overall Study | Transferred From RPC1063 0.5 mg Parent Group | Parent Treatment Group: RPC1063 0.5 mg | 0 | |
| Overall Study | Transferred From RPC1063 0.5 mg Parent Group | Parent Treatment Group: RPC1063 1.0 mg | 1 | |
| Overall Study | Randomized to Placebo in the Parent Study | Parent Treatment Group IFN-B-1a 30 ug | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,730
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 | Anaemia | Blood and lymphatic system disorders | Parent Treatment Group: Placebo for RPC1063 0.5 mg | 4 | 37 | |
| other | Anaemia | Blood and lymphatic system disorders | Parent Treatment Group: Placebo for RPC1063 1 mg | 4 | 35 | |
| other | Anaemia | Blood and lymphatic system disorders | Parent Treatment Group IFN-B-1a 30 ug | 28 | 736 | |
| other | Anaemia | Blood and lymphatic system disorders | Parent Treatment Group: RPC1063 0.5 mg | 31 | 840 | |
| other | Anaemia | Blood and lymphatic system disorders | Parent Treatment Group: RPC1063 1.0 mg | 36 | 846 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Parent Treatment Group: Placebo for RPC1063 0.5 mg | 3 | 37 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Parent Treatment Group: Placebo for RPC1063 1 mg | 6 | 35 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Parent Treatment Group IFN-B-1a 30 ug | 83 | 736 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Parent Treatment Group: RPC1063 0.5 mg | 92 | 840 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Parent Treatment Group: RPC1063 1.0 mg | 73 | 846 |
1 to 10 of 1,730Source ClinicalTrials.gov
See all 1,730 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Parent Treatment Group: Placebo for RPC1063 0.5 mg | 0 | 37 |
| Total, all-cause mortality | Parent Treatment Group: Placebo for RPC1063 1 mg | 0 | 35 |
| Total, all-cause mortality | Parent Treatment Group IFN-B-1a 30 ug | 6 | 736 |
| Total, all-cause mortality | Parent Treatment Group: RPC1063 0.5 mg | 5 | 840 |
| Total, all-cause mortality | Parent Treatment Group: RPC1063 1.0 mg | 5 | 846 |
| Total, other adverse events | Parent Treatment Group: Placebo for RPC1063 0.5 mg | 27 | 37 |
| Total, other adverse events | Parent Treatment Group: Placebo for RPC1063 1 mg | 26 | 35 |
| Total, other adverse events | Parent Treatment Group IFN-B-1a 30 ug | 598 | 736 |
| Total, other adverse events | Parent Treatment Group: RPC1063 0.5 mg | 663 | 840 |
| Total, other adverse events | Parent Treatment Group: RPC1063 1.0 mg | 659 | 846 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers6
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.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Coding | Secondary outcome |
Source ConductCognition
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.
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02576717
GET https://conductscience.org/api/trials/v1/NCT02576717/registered?page=2