Trial · NCT02531633
Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
NCT02531633, Phase 3, Terminated, GlaxoSmithKline; results first posted 2019-05-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis. Trials, record NCT02531633. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02531633
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
- NCT number
- NCT02531633
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 161 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Giant Cell Arteritis
- Interventions
- Sirukumab, Placebo to match sirukumab, Prednisone, Placebo to match prednisone
- First posted
- 2015-08-24
- Last updated
- 2019-07-31
- Results first posted
- 2019-05-31
Source ClinicalTrials.gov
Registered outcomes92
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Number of Participants in Sustained Remission at Week 52 | Week 52 | Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) \[\<30 millimeters per hour\] and C-reactive Protein (CRP) \[\<1 milligram/deciliter\]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis. |
| Secondary | Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24 | Week 24 | Participants who remained in sustained remission without requirement for rescue therapy or treatment change at each scheduled visit of Part B were defined as participants having achieved all of the following criteria: 1. Participants in sustained remission at the Week 52 visit of Part A, 2. Absence of disease flare, 3. No requirement for rescue therapy at any time through Week 24 of Part B, 4. No requirement for treatment change at any time through Week 24 of Part B. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR \[\<30 millimeters per hour\] and CRP \[\<1 milligram/deciliter\]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. |
| Secondary | Part A: Cumulative Prednisone Dose Over Time | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | Cumulative prednisone is the dose from the taper (both open-label and blinded) as well as from the corticosteroid rescue therapies. Cumulative dose at the specified Week was derived as the sum of all the doses from Baseline to the specified Week at each visit was calculated based on the number of participants who attended that visit. For the main analysis of cumulative prednisone dose over time. Data for Prednisone Dose- Study Drug and Prednisone Equivalent Concomitant Therapy for part A is presented. ITT population and the number of participants included at specific time points were based on the participants who attended a scheduled or unscheduled visit mapped to that time point and received a total prednisone dose greater than 0 mg. |
| Secondary | Part B: Number of Participants in Sustained Remission Over Time | Weeks 4, 8 and 12 | Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR \[\<30millimeters per hour\] and CRP \[\<1milligram/deciliter\]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis. |
| Secondary | Part A: Time to First Disease Flare After Clinical Remission | Week 52 | Clinical remission was defined as absence of clinical signs and symptoms of GCA, which was determined by a lack of flare for the participant. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to first disease flare (days) was calculated as (Date of First Flare - Date of Clinical Remission + 1 day). Data for Time to first disease flare after clinical remission for part A is presented. |
| Secondary | Part B: Time to First Disease Flare for Participants in Sustained Remission | Week 52 | Clinical remission was defined as absence of clinical signs and symptoms of GCA. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to event (days) is defined as the duration in days from the date of the Week 52 visit of Part A to the start date of Event (Date of First Flare - Date of Week 52 visit of Part A + 1). Data for Time to first disease flare after clinical remission for part B is presented. |
| Secondary | Part A: Number of Disease Flares Over Time | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants; participants who did not reach Week 2 were not included in this analysis. Data for number of disease flares per participant over time for part A were presented. |
| Secondary | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | Number of participants with at least one hospitalization for disease flare at a given visit is the number of participants with at least one hospitalization for disease flare between first SC IP intake and the day of the given visit. Data for participants requiring at least one hospitalization for disease flare for part A is presented. |
| Secondary | Part A: Number of Hospitalizations for Disease Flare Over Time | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | Number of hospitalizations for disease flare at given visit is the number of hospitalizations for disease flare between first SC IP intake and the day of the of the given visit.. Data for number of hospitalizations for disease flare over time for part A was presented. |
| Secondary | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | Baseline (Week 0), Weeks 12, 24, 36, 52 | SF-36v2 acute health survey questionnaire consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for Physical Component Summary (PCS), Mental Component Summary (MCS) scores was presented. |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 registered outcomesOutcomes92
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Number of Participants in Sustained Remission at Week 52 | Week 52 | Intent-to-Treat (ITT) Population comprised of all randomized participants who received at least 1 dose of SC investigational product (IP). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24 | Week 24 | ITT-Part B Population included all randomized participants who received at least 1 dose of SC IP in Part A and entered Part B. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Cumulative Prednisone Dose Over Time | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Milligrams | MEAN |
| SECONDARY | Part B: Number of Participants in Sustained Remission Over Time | Weeks 4, 8 and 12 | ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Time to First Disease Flare After Clinical Remission | Week 52 | ITT Population. Only participants who achieved clinical remission were included in this analysis. | Days | MEDIAN |
| SECONDARY | Part B: Time to First Disease Flare for Participants in Sustained Remission | Week 52 | ITT-Part B Population. Only those participants with available data at the specified time points were analyzed. | Days | MEDIAN |
| SECONDARY | Part A: Number of Disease Flares Over Time | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Disease flares | NUMBER |
| SECONDARY | Part A: Number of Participants With at Least One Hospitalization for Disease Flare | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Number of Hospitalizations for Disease Flare Over Time | Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 | ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Number of Hospitalizations | NUMBER |
| SECONDARY | Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time | Baseline (Week 0), Weeks 12, 24, 36, 52 | ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). | Scores on scale | MEAN |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 outcomesResults by group9,857
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Number of Participants in Sustained Remission at Week 52 | PartA:SIR 100 mg SC q2w+6 Month Prednisone | 3 | Participants | ||
| Part A: Number of Participants in Sustained Remission at Week 52 | PartA:SIR 100 mg SC q2w+3 Month Prednisone | 2 | Participants | ||
| Part A: Number of Participants in Sustained Remission at Week 52 | PartA:SIR 50 mg SC q4w+6 Month Prednisone | 1 | Participants | ||
| Part A: Number of Participants in Sustained Remission at Week 52 | PartA:Placebo SC q2w + 6 Month Prednisone | 0 | Participants | ||
| Part A: Number of Participants in Sustained Remission at Week 52 | PartA:Placebo SC q2w + 12 Month Prednisone | 0 | Participants | ||
| Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24 | PartB:SIR 100 mg SC q2w+6 Month Prednisone | NA | Participants | ||
| Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24 | Part B:SIR 100 mg SC q2w+3 Month Prednisone | NA | Participants | ||
| Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24 | PartB:SIR 50 mg SC q4w+6 Month Prednisone | NA | Participants | ||
| Part A: Cumulative Prednisone Dose Over Time | PartA:SIR 100 mg SC q2w+6 Month Prednisone | Week 2, n= 40,39,26,27,26 | 439.575 | Standard Deviation 237.8990 | Milligrams |
| Part A: Cumulative Prednisone Dose Over Time | PartA:SIR 100 mg SC q2w+3 Month Prednisone | Week 2, n= 40,39,26,27,26 | 464.923 | Standard Deviation 299.6445 | Milligrams |
1 to 10 of 9,857Source ClinicalTrials.gov
See all 9,857 results by groupParticipant flow70
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (52 Weeks) | STARTED | Part A:SIR 100 mg SC q2w+6 Month Prednisone | 42 | |
| Part A (52 Weeks) | STARTED | Part A:SIR 100 mg SC q2w+3 Month Prednisone | 39 | |
| Part A (52 Weeks) | STARTED | Part A:SIR 50 mg SC q4w+6 Month Prednisone | 26 | |
| Part A (52 Weeks) | STARTED | Part A:Placebo SC q2w + 6 Month Prednisone | 27 | |
| Part A (52 Weeks) | STARTED | Part A:Placebo SC q2w+12 Month Prednisone | 27 | |
| Part A (52 Weeks) | STARTED | Part B:SIR 100 mg SC q2w+6 Month Prednisone | 0 | |
| Part A (52 Weeks) | STARTED | Part B:SIR 100 mg SC q2w+3 Month Prednisone | 0 | |
| Part A (52 Weeks) | STARTED | Part B:SIR 50 mg SC q4w+6 Month Prednisone | 0 | |
| Part A (52 Weeks) | STARTED | Part B:Placebo SC q2w + 6 Month Prednisone | 0 | |
| Part A (52 Weeks) | STARTED | Part B:Placebo SC q2w + 12 Month Prednisone | 0 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 participant flowAdverse events2,040
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Part A:SIR 100 mg SC q2w+6 Month Prednisone | 5 | 42 | 7 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Part A:SIR 100 mg SC q2w+3 Month Prednisone | 4 | 39 | 36 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Part A: SIR 50 mg SC q4w+6 Month Prednisone | 5 | 26 | 6 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Part A:Placebo SC q2w + 6 Month Prednisone | 1 | 27 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Part A:Placebo SC q2w + 12 Month Prednisone | 4 | 27 | 6 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Part B:SIR 100 mg SC q2w+6 Month Prednisone+100mg OL SIR | 0 | 2 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Part B:SIR 100 mg SC q2w+3 Month Prednisone+100mg OL SIR | 0 | 1 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Part B:SIR 50 mg SC q4w+6 Month Prednisone+100mg OL SIR | 0 | 1 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Part B:Placebo SC q2w + 6 Month Prednisone+100mg OL SIR | 0 | 2 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Part B:Placebo SC q2w + 12 Month Prednisone+100mg OL SIR | 0 | 2 | 0 |
1 to 10 of 2,040Source ClinicalTrials.gov
See all 2,040 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A:SIR 100 mg SC q2w+6 Month Prednisone | 0 | 42 |
| Total, all-cause mortality | Part A:SIR 100 mg SC q2w+3 Month Prednisone | 0 | 39 |
| Total, all-cause mortality | Part A: SIR 50 mg SC q4w+6 Month Prednisone | 0 | 26 |
| Total, all-cause mortality | Part A:Placebo SC q2w + 6 Month Prednisone | 0 | 27 |
| Total, all-cause mortality | Part A:Placebo SC q2w + 12 Month Prednisone | 0 | 27 |
| Total, all-cause mortality | Part B:SIR 100 mg SC q2w+6 Month Prednisone+100mg OL SIR | 0 | 2 |
| Total, all-cause mortality | Part B:SIR 100 mg SC q2w+3 Month Prednisone+100mg OL SIR | 0 | 1 |
| Total, all-cause mortality | Part B:SIR 50 mg SC q4w+6 Month Prednisone+100mg OL SIR | 0 | 1 |
| Total, all-cause mortality | Part B:Placebo SC q2w + 6 Month Prednisone+100mg OL SIR | 0 | 2 |
| Total, all-cause mortality | Part B:Placebo SC q2w + 12 Month Prednisone+100mg OL SIR | 0 | 2 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32844378 | DERIVED |
Source PubMed
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/NCT02531633
GET https://conductscience.org/api/trials/v1/NCT02531633/registered?page=2