Trial · NCT01283139
A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
NCT01283139, Phase 2, Completed, MedImmune LLC; results first posted 2016-07-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus. Trials, record NCT01283139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01283139
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
- NCT number
- NCT01283139
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 834 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Sifalimumab 200 mg, Sifalimumab 600 mg, Sifalimumab 1,200 mg, Placebo
- First posted
- 2011-01-25
- Last updated
- 2018-04-19
- Other registries' IDs
- eudract:2010-024069-30
- Results first posted
- 2016-07-11
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) | Day 365 | SRI (4) responder is defined as: 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (\>=) 4 points (with increased deoxyribonucleic acid \[DNA\] binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in British Isles Lupus Assessment Group (BILAG-2004) (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline). |
| Primary | Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants | Day 365 | SRI (4) responder is defined as: 1) a reduction in baseline SLEDAI-2K disease activity score of \>=4 points (with increased DNA binding item of SLEDAI-2K score based on the ANA Multi-Lyte® ANA-II Plus Test System); 2) no worsening in Physician Global Assessment (MDGA) (worsening is defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale) and 3) no worsening in BILAG-2004 (worsening is defined as at least 1 new 'A' score or 2 new 'B' scores on the BILAG-2004 compared with baseline). |
| Secondary | Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Day 365 | Percentage of participants on \>=10 mg/day oral corticosteroids (OCS) at baseline who were able to taper it to \<=7.5 mg/day by Day 365 were recorded. |
| Secondary | Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction | Day 365 | The CLASI consists of two scores, the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. The percentage of participants with a CLASI activity score \>=10 at baseline who achieved a clinically significant (\>=4-point) reduction at Day 365 were reported. |
| Secondary | Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Day 365 | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | Day 1 up to Week 74 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of investigational product, for the period extending until the end of participant participation in the study. |
| Secondary | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Day 1 up to Week 61 | Laboratory investigations included hematology, serum chemistries and urinalysis parameters. Participants with clinically significant abnormalities in these laboratory investigations recorded as TEAEs were reported. |
| Secondary | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Day 1 up to Week 61 | Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiratory rate. Vital signs abnormalities recorded as TEAEs were reported. |
| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | Day 1 up to Week 56 | The 12-lead ECG data were summarized and evaluated. Number of participants with clinically significant abnormal ECG findings as assessed by cardiologist were recorded and reported as TEAEs. |
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 | Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) | Day 365 | The modified intent-to-treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants | Day 365 | The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with positive diagnostic test. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Day 365 | The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants on \>=10 mg/day oral prednisone (or equivalent) at baseline. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Cutaneous Lupus Erythematosus Disease Activity and Severity Index (CLASI) Activity Score Greater Than or Equal to (>=) 10 at Baseline Who Achieved a >= 4-point Reduction | Day 365 | The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with a CLASI activity score \>=10 at baseline. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Greater Than 3-Point Improvement in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Day 365 | The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies number of participants with a FACIT-fatigue score \<49 at baseline. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) | Day 1 up to Week 74 | The safety population included all participants who received any investigational product. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Day 1 up to Week 61 | The safety population included all participants who received any investigational product. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Day 1 up to Week 61 | The safety population included all participants who received any investigational product. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | Day 1 up to Week 56 | The safety population included all participants who received any investigational product. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group272
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) | Placebo | 45.4 | percentage of participants | ||
| Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) | Sifalimumab 200 Milligram (mg) | 58.3 | percentage of participants | ||
| Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) | Sifalimumab 600 mg | 56.5 | percentage of participants | ||
| Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) | Sifalimumab 1,200 mg | 59.8 | percentage of participants | ||
| Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants | Placebo | 42.0 | percentage of participants | ||
| Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants | Sifalimumab 200 Milligram (mg) | 57.5 | percentage of participants | ||
| Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants | Sifalimumab 600 mg | 50.0 | percentage of participants | ||
| Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants | Sifalimumab 1,200 mg | 57.5 | percentage of participants | ||
| Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Placebo | Reduce OCS to <=7.5 mg/day: Yes | 6.5 | percentage of participants | |
| Percentage of Participants on Greater Than or Equal to 10 mg/Day Oral Prednisone (or Equivalent) at Baseline Who Were Able to Reduce to Less Than or Equal to (<=) 7.5 mg/Day | Sifalimumab 200 Milligram (mg) | Reduce OCS to <=7.5 mg/day: Yes | 8.2 | percentage of participants |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 108 | |
| Overall Study | STARTED | Sifalimumab 200 Milligram (mg) | 108 | |
| Overall Study | STARTED | Sifalimumab 600 mg | 109 | |
| Overall Study | STARTED | Sifalimumab 1,200 mg | 107 | |
| Overall Study | COMPLETED | Placebo | 91 | |
| Overall Study | COMPLETED | Sifalimumab 200 Milligram (mg) | 90 | |
| Overall Study | COMPLETED | Sifalimumab 600 mg | 91 | |
| Overall Study | COMPLETED | Sifalimumab 1,200 mg | 92 | |
| Overall Study | NOT COMPLETED | Placebo | 17 | |
| Overall Study | NOT COMPLETED | Sifalimumab 200 Milligram (mg) | 18 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events500
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 | Placebo | 1 | 108 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Sifalimumab 200 mg | 3 | 108 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Sifalimumab 600 mg | 4 | 108 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Sifalimumab 1200 mg | 1 | 107 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 2 | 108 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Sifalimumab 200 mg | 0 | 108 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Sifalimumab 600 mg | 6 | 108 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | Sifalimumab 1200 mg | 4 | 107 | 4 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 4 | 108 | 5 |
| other | Abdominal pain upper | Gastrointestinal disorders | Sifalimumab 200 mg | 1 | 108 | 1 |
1 to 10 of 500Source ClinicalTrials.gov
See all 500 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Sifalimumab 200 mg | ||
| Total, all-cause mortality | Sifalimumab 600 mg | ||
| Total, all-cause mortality | Sifalimumab 1200 mg | ||
| Total, other adverse events | Placebo | 93 | 108 |
| Total, other adverse events | Sifalimumab 200 mg | 94 | 108 |
| Total, other adverse events | Sifalimumab 600 mg | 96 | 108 |
| Total, other adverse events | Sifalimumab 1200 mg | 92 | 107 |
| Total, serious adverse events | Placebo | 19 | 108 |
| Total, serious adverse events | Sifalimumab 200 mg | 16 | 108 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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/NCT01283139
GET https://conductscience.org/api/trials/v1/NCT01283139/results?page=2