Trial · NCT02347891
Belimumab in Idiopathic Inflammatory Myositis
NCT02347891, Phase 2, Phase 3, Completed, Northwell Health; results first posted 2024-02-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Belimumab in Idiopathic Inflammatory Myositis. Trials, record NCT02347891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02347891
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Belimumab in Idiopathic Inflammatory Myositis
- NCT number
- NCT02347891
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 17 participants, actual
- Lead sponsor
- Northwell Health
- Conditions
- Myositis
- Interventions
- Belimumab, Placebo
- First posted
- 2015-01-28
- Last updated
- 2024-02-09
- Results first posted
- 2024-02-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate During Randomized Phase | 40 weeks | Definition of Improvement (DOI) is ≥ 20% of improvement in any 3 of the core set measures (CSM) - Manual Muscle Testing, Patient Global , Physician Global, Muscle Enzyme change , HAQ and Extra- muscular activity and no more than 2 CSM worsening by ≥ 25% (excluding MMT). Total Improvement Score ( TIS) is a sum of weighted scores of absolute change of core set measures ( MMT, Patient Global , Physician Global, Muscle Enzyme change , HAQ and Extra-muscluar activity ). The scores range from 0 to 100, with higher scores indicating greater improvement. TIS ≥ 40 indicates a moderate response and ≥ 60 TIS indicates a major response. |
| Primary | Mean Total Improvement Score (TIS) During Randomized Phase | 40 Week | It is a composite measure calculated as a sum of weighted scores assigned to absolute changes for each measure (MMT , Patient Global, Physician Global, Muscle enzymes, Extramuscluar activity and HAQ) . Total score could range from 0 to 100. TIS ≥ 20 indicates minimal improvement, TIS ≥ 40 indicates moderate response and TIS ≥ 60 indicates a major response. 2016 ACR/EULAR Criteria for Minimal, Moderate, and Major Clinical Response in Adult Dermatomyositis and Polymyositis and Juvenile Dermatomyositis (Aggarwal R et al 2016) |
| Secondary | Response Rate After Open Label Phase | 64 weeks | It is a composite measure calculated as a sum of weighted scores assigned to absolute changes for each measure (MMT , Patient Global, Physician Global, Muscle enzymes, Extramuscluar activity and HAQ) . Total score could range from 0 to 100. TIS ≥ 20 indicates minimal improvement, TIS ≥ 40 indicates moderate response and TIS ≥ 60 indicates a major response. 2016 ACR/EULAR Criteria for Minimal, Moderate, and Major Clinical Response in Adult Dermatomyositis and Polymyositis and Juvenile Dermatomyositis (Aggarwal R et al 2016) |
| Secondary | Mean Total Improvement Score (TIS) After Open Label Phase | 64 Week | Definition of Improvement (DOI) is ≥ 20% of improvement in any 3 of the core set measures (CSM) - Manual Muscle Testing, Patient Global , Physician Global, Muscle Enzyme change , HAQ and Extra- muscular activity and no more than 2 CSM worsening by ≥ 25% (excluding MMT). Total Improvement Score ( TIS) is a sum of weighted scores of absolute change of core set measures ( MMT, Patient Global , Physician Global, Muscle Enzyme change , HAQ and Extra-muscluar activity ). The scores range from 0 to 100, with higher scores indicating greater improvement. TIS ≥ 40 indicates a moderate response and ≥ 60 TIS indicates a major response. Minimal, Moderate, and Major Clinical Response in Adult Dermatomyositis and Polymyositis and Juvenile Dermatomyositis (Aggarwal R et al 2016) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate During Randomized Phase | 40 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Mean Total Improvement Score (TIS) During Randomized Phase | 40 Week | score on a scale | MEAN | |
| SECONDARY | Response Rate After Open Label Phase | 64 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Total Improvement Score (TIS) After Open Label Phase | 64 Week | In originally assigned Belimumab group 9 patients completed week 16, 8 completed week 40, 7 completed week 64 In originally assigned placebo group 6 patients completed week 16, 6 completed week 40, 5 completed week 64 The response scores at week 40 and 64 were calculated based on number of patients that completed 16 weeks of study | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate During Randomized Phase | Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) | Week 40 : Definition of Improvement (DOI) | 3 | Participants | |
| Response Rate During Randomized Phase | Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase) | Week 40 : Definition of Improvement (DOI) | 1 | Participants | |
| Response Rate During Randomized Phase | Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) | Week 40 : Percent patients reaching Total improvement score of ≥40 | 5 | Participants | |
| Response Rate During Randomized Phase | Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase) | Week 40 : Percent patients reaching Total improvement score of ≥40 | 2 | Participants | |
| Response Rate During Randomized Phase | Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) | Week 40 : Percent of patient with major improvement TIS ≥60 | 2 | Participants | |
| Response Rate During Randomized Phase | Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase) | Week 40 : Percent of patient with major improvement TIS ≥60 | 0 | Participants | |
| Mean Total Improvement Score (TIS) During Randomized Phase | Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) | 38.8 | Standard Deviation 24.9 | score on a scale | |
| Mean Total Improvement Score (TIS) During Randomized Phase | Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase) | 37.9 | Standard Deviation 5.8 | score on a scale | |
| Response Rate After Open Label Phase | Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) | Week 64 : Definition of Improvement (DOI) | 3 | Participants | |
| Response Rate After Open Label Phase | Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase) | Week 64 : Definition of Improvement (DOI) | 0 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Week 0 - Week 40 (Randomized Phase) | STARTED | Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) | 10 | |
| Week 0 - Week 40 (Randomized Phase) | STARTED | Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase) | 7 | |
| Week 0 - Week 40 (Randomized Phase) | Received 5 Doses and Included in Included in the Final Intention-to-treat Analysis | Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) | 9 | |
| Week 0 - Week 40 (Randomized Phase) | Received 5 Doses and Included in Included in the Final Intention-to-treat Analysis | Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase) | 6 | |
| Week 0 - Week 40 (Randomized Phase) | COMPLETED | Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) | 8 | |
| Week 0 - Week 40 (Randomized Phase) | COMPLETED | Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase) | 6 | |
| Week 0 - Week 40 (Randomized Phase) | NOT COMPLETED | Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) | 2 | |
| Week 0 - Week 40 (Randomized Phase) | NOT COMPLETED | Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase) | 1 | |
| Week 40 - Week 64 (Open Lable Phase) | STARTED | Arm 1 (Belimumab + SoC (Randomized Phase and Open Label Phase) | 8 | |
| Week 40 - Week 64 (Open Lable Phase) | STARTED | Arm 2 (Placebo + SoC (Randomized Phase) Followed by Belimumab + SoC (Open Label Phase) | 6 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse 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 | Upper respiratory infection | Infections and infestations | Arm 1 (Belimumab + SoC (Randomized Phase) | 2 | 10 | 2 |
| other | Upper respiratory infection | Infections and infestations | Arm 2 (Placebo + SoC (Randomized Phase) | 3 | 7 | 5 |
| other | Upper respiratory infection | Infections and infestations | Open Label Arm 1 and 2 Combined | 1 | 14 | 1 |
| other | Urinary Tract Infection | Infections and infestations | Arm 1 (Belimumab + SoC (Randomized Phase) | 0 | 10 | |
| other | Urinary Tract Infection | Infections and infestations | Arm 2 (Placebo + SoC (Randomized Phase) | 1 | 7 | |
| other | Urinary Tract Infection | Infections and infestations | Open Label Arm 1 and 2 Combined | 1 | 14 | |
| other | Adjustment disorder | Psychiatric disorders | Arm 1 (Belimumab + SoC (Randomized Phase) | 1 | 10 | |
| other | Adjustment disorder | Psychiatric disorders | Arm 2 (Placebo + SoC (Randomized Phase) | 0 | 7 | |
| other | Adjustment disorder | Psychiatric disorders | Open Label Arm 1 and 2 Combined | 0 | 14 | |
| other | Transaminitis | Hepatobiliary disorders | Arm 1 (Belimumab + SoC (Randomized Phase) | 1 | 10 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 (Belimumab + SoC (Randomized Phase) | 6 | 10 |
| Total, all-cause mortality | Arm 2 (Placebo + SoC (Randomized Phase) | 6 | 7 |
| Total, all-cause mortality | Open Label Arm 1 and 2 Combined | 6 | 14 |
| Total, other adverse events | Arm 1 (Belimumab + SoC (Randomized Phase) | 5 | 10 |
| Total, other adverse events | Arm 2 (Placebo + SoC (Randomized Phase) | 6 | 7 |
| Total, other adverse events | Open Label Arm 1 and 2 Combined | 6 | 14 |
| Total, serious adverse events | Arm 1 (Belimumab + SoC (Randomized Phase) | 1 | 10 |
| Total, serious adverse events | Arm 2 (Placebo + SoC (Randomized Phase) | 0 | 7 |
| Total, serious adverse events | Open Label Arm 1 and 2 Combined | 0 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37326854 | 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/NCT02347891
GET https://conductscience.org/api/trials/v1/NCT02347891/events?page=2