Trial · NCT00979654
A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis
NCT00979654, Phase 2, Completed, MedImmune LLC; results first posted 2016-08-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis. Trials, record NCT00979654. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00979654
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis
- NCT number
- NCT00979654
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 118 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Sifalimumab
- First posted
- 2009-09-18
- Last updated
- 2016-10-27
- Results first posted
- 2016-08-23
- Limitations and caveats
- A business decision was made to discontinue the development of sifalimumab in favor of another type 1 interferon (IFN) inhibitor.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From start of study drug administration until week 182 | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of investigational product and 30 days after the last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. |
| Secondary | Maximum Observed Serum Concentration (Cmax) for Sifalimumab | Pre-infusion and End of Infusion on Day 1 | The Cmax is the maximum observed plasma concentration of sifalimumab. |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab | Pre-infusion and End of Infusion on Day 1 | The Tmax is the time to reach maximum observed plasma concentration of sifalimumab. |
| Secondary | Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab | Pre-infusion and End of Infusion on Day 1 | The Tlast is the time to last quantifiable plasma concentration (Tlast) of sifalimumab. |
| Secondary | Minimum Observed Serum Concentration (Ctrough) of Sifalimumab | Pre-infusion and End of Infusion on Day 1 | The Ctrough is the minimum observed serum concentration of sifalimumab. |
| Secondary | Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab | Pre-infusion and End of Infusion on Day 1 | The AUCtau is the area under the serum concentration-time curve over the dosing interval of sifalimumab. |
| Secondary | Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Sifalimumab | Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168 | The Ctrough is the minimum observed serum concentration at steady state of sifalimumab. |
| Secondary | Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of Sifalimumab | Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168 | The Ctrough is the minimum observed serum concentration of sifalimumab. Accumulation Index is calculated as Ctrough value at steady state divided by Ctrough value after first dose. |
| Secondary | Number of Participants With Positive Anti-Drug Antibody | Day 1 and Week 12, 24, 52, 104, 156 and 168 | Participants tested for immunogenicity to Sifalimumab (MEDI-545) from Day 1 to the end of study. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From start of study drug administration until week 182 | Safety Population included all participants who received at least one dose of investigational product. | participants | NUMBER |
| SECONDARY | Maximum Observed Serum Concentration (Cmax) for Sifalimumab | Pre-infusion and End of Infusion on Day 1 | The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, N is number of participants analyzed for this outcome measure. | microgram per milliliter (mcg/mL) | MEAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab | Pre-infusion and End of Infusion on Day 1 | The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, N is number of participants analyzed for this outcome measure. | days | MEDIAN |
| SECONDARY | Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab | Pre-infusion and End of Infusion on Day 1 | The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, N is number of participants analyzed for this outcome measure. | days | MEAN |
| SECONDARY | Minimum Observed Serum Concentration (Ctrough) of Sifalimumab | Pre-infusion and End of Infusion on Day 1 | The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, N is number of participants analyzed for this outcome measure. | mcg/mL | MEAN |
| SECONDARY | Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab | Pre-infusion and End of Infusion on Day 1 | The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, N is number of participants analyzed for this outcome measure. | microgram.day per milliliter(mcg*day/mL) | MEAN |
| SECONDARY | Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Sifalimumab | Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168 | The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, N is number of participants analyzed for this outcome measure. | mcg/mL | MEAN |
| SECONDARY | Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of Sifalimumab | Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168 | The PK Population included all participants who received at least one dose of investigational product and had at least one evaluable sifalimumab serum concentration. Here, N is number of participants analyzed for this outcome measure. | ratio | MEAN |
| SECONDARY | Number of Participants With Positive Anti-Drug Antibody | Day 1 and Week 12, 24, 52, 104, 156 and 168 | Safety Population included all participants who received at least one dose of investigational product. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Sifalimumab (MEDI-545) 500 or 600 Milligram (mg) | TEAEs | 101 | participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Sifalimumab (MEDI-545) 500 or 600 Milligram (mg) | TESAEs | 27 | participants | |
| Maximum Observed Serum Concentration (Cmax) for Sifalimumab | Sifalimumab (MEDI-545) 500 or 600 Milligram (mg) | 225.569 | Standard Deviation 78.842 | microgram per milliliter (mcg/mL) | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab | Sifalimumab (MEDI-545) 500 or 600 Milligram (mg) | 0.049 | Full Range 0.04 to 0.13 | days | |
| Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab | Sifalimumab (MEDI-545) 500 or 600 Milligram (mg) | 14.413 | Standard Deviation 1.693 | days | |
| Minimum Observed Serum Concentration (Ctrough) of Sifalimumab | Sifalimumab (MEDI-545) 500 or 600 Milligram (mg) | 65.009 | Standard Deviation 30.516 | mcg/mL | |
| Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab | Sifalimumab (MEDI-545) 500 or 600 Milligram (mg) | 2084.180 | Standard Deviation 665.882 | microgram.day per milliliter(mcg*day/mL) | |
| Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Sifalimumab | Sifalimumab (MEDI-545) 500 or 600 Milligram (mg) | 78.731 | Standard Deviation 53.942 | mcg/mL | |
| Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of Sifalimumab | Sifalimumab (MEDI-545) 500 or 600 Milligram (mg) | 1.217 | Standard Deviation 0.808 | ratio | |
| Number of Participants With Positive Anti-Drug Antibody | Sifalimumab (MEDI-545) 500 or 600 Milligram (mg) | Day 1 | 5 | Participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MEDI-545 | 103 | |
| Overall Study | COMPLETED | MEDI-545 | 67 | |
| Overall Study | NOT COMPLETED | MEDI-545 | 36 |
Source ClinicalTrials.gov
Adverse events77
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 | Abdominal pain | Gastrointestinal disorders | MEDI-545 | 6 | 103 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | MEDI-545 | 16 | 103 | 24 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | MEDI-545 | 6 | 103 | 6 |
| other | Nausea | Gastrointestinal disorders | MEDI-545 | 20 | 103 | 28 |
| other | Vomiting | Gastrointestinal disorders | MEDI-545 | 11 | 103 | 17 |
| other | Fatigue | General disorders | MEDI-545 | 8 | 103 | 9 |
| other | Seasonal allergy | Immune system disorders | MEDI-545 | 7 | 103 | 7 |
| other | Bronchitis | Infections and infestations | MEDI-545 | 23 | 103 | 36 |
| other | Gastroenteritis | Infections and infestations | MEDI-545 | 7 | 103 | 7 |
| other | Gastroenteritis viral | Infections and infestations | MEDI-545 | 6 | 103 | 10 |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MEDI-545 | ||
| Total, other adverse events | MEDI-545 | 89 | 103 |
| Total, serious adverse events | MEDI-545 | 27 | 103 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00979654
GET https://conductscience.org/api/trials/v1/NCT00979654/events?page=2