Trial · NCT02270957
Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches
NCT02270957, Phase 2, Completed, Oklahoma Medical Research Foundation; results first posted 2020-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches. Trials, record NCT02270957. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02270957
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches
- NCT number
- NCT02270957
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- Oklahoma Medical Research Foundation
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Abatacept, Placebo
- First posted
- 2014-10-22
- Last updated
- 2022-01-26
- Results first posted
- 2020-11-25
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA) | 6 months | The British Isles Lupus Assessment Group Index is a scoring system for progress of disease activity over the prior month with a scoring system that rates each organ system as "A" or severe, "B" or moderate, "C" or mild vs no activity in the past month. To meet the BICLA endpoint requires all baseline severe features (BILAG A) improving to moderate (BILAG B), mild or resolved, and all baseline BILAG B features improving to mild or resolved without increase in any other feature on either the BILAG or a different measure called the SLEDAI (SLE Disease Activity Index). Furthermore there must be no increase in Physician's Global Assessment or any rescue medications after the month 2 visit. Only those meeting all of these criteria meet the primary endpoint. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA) | 6 months | Full Analysis Set: All Randomized Patients | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | SLE Responder Index-4 (SRI-4) | 6 months | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | 4 Point Improvement in the SLE Disease Activity Index (SLEDAI) | Comparison of Baseline to 6 months | Full Analysis Set of all randomized patients | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA) | Abatacept | 8 | Participants | ||
| British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA) | Placebo | 8 | Participants | ||
| SLE Responder Index-4 (SRI-4) | Abatacept | 9 | Participants | ||
| SLE Responder Index-4 (SRI-4) | Placebo | 8 | Participants | ||
| 4 Point Improvement in the SLE Disease Activity Index (SLEDAI) | Abatacept | 9 | Participants | ||
| 4 Point Improvement in the SLE Disease Activity Index (SLEDAI) | Placebo | 8 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abatacept | 31 | |
| Overall Study | STARTED | Placebo | 35 | |
| Overall Study | COMPLETED | Abatacept | 27 | |
| Overall Study | COMPLETED | Placebo | 31 | |
| Overall Study | NOT COMPLETED | Abatacept | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events44
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 | bronchitis | Respiratory, thoracic and mediastinal disorders | Abatacept | 5 | 31 | 5 |
| other | bronchitis | Respiratory, thoracic and mediastinal disorders | Placebo | 4 | 35 | 5 |
| other | gastroenteritis | Gastrointestinal disorders | Abatacept | 17 | 31 | 18 |
| other | gastroenteritis | Gastrointestinal disorders | Placebo | 11 | 35 | 11 |
| other | oral candida | Infections and infestations | Abatacept | 0 | 31 | 0 |
| other | oral candida | Infections and infestations | Placebo | 8 | 35 | 8 |
| other | injection site reaction | Injury, poisoning and procedural complications | Abatacept | 4 | 31 | 4 |
| other | injection site reaction | Injury, poisoning and procedural complications | Placebo | 3 | 35 | 4 |
| other | rash | Skin and subcutaneous tissue disorders | Abatacept | 2 | 31 | 2 |
| other | rash | Skin and subcutaneous tissue disorders | Placebo | 4 | 35 | 6 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abatacept | 0 | 31 |
| Total, all-cause mortality | Placebo | 0 | 35 |
| Total, other adverse events | Abatacept | 29 | 31 |
| Total, other adverse events | Placebo | 35 | 35 |
| Total, serious adverse events | Abatacept | 6 | 31 |
| Total, serious adverse events | Placebo | 4 | 35 |
Source ClinicalTrials.gov
Papers2
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Abatacept vs Placebo: 4 Point Improvement in the SLE Disease Activity Index (SLEDAI) | Trial comparisons |
| Abatacept vs Placebo: SLE Responder Index-4 (SRI-4) | Trial comparisons |
| Abatacept vs Placebo: British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA) | Trial comparisons |
| Abatacept vs Placebo: deaths from any cause | Trial comparisons |
| Abatacept vs Placebo: serious adverse events | Trial comparisons |
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/NCT02270957
GET https://conductscience.org/api/trials/v1/NCT02270957/events?page=2