Trial · NCT00556439
Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis
NCT00556439, Phase 2, Completed, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); results first posted 2018-02-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis. Trials, record NCT00556439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00556439
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis
- NCT number
- NCT00556439
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 97 participants, actual
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Conditions
- Takayasu's Arteritis, Giant Cell Arteritis
- Interventions
- Abatacept, Placebo
- First posted
- 2007-11-12
- Last updated
- 2018-02-26
- Results first posted
- 2018-02-26
- Limitations and caveats
Small sample size, challenges in assessing disease activity in giant cell arteritis and Takayasu arteritis, 84.6% of patients with Takayasu arteritis were enrolled for the treatment of a disease relapse.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Outcome - Relapse-free Survival (RFS) | Weeks 0 to 64 | Relapse: presence of active disease occurring after a period of remission Remission: absence of active disease Active disease defined by clinical features or imaging or both: Clinical features: 1 or more of the following attributed to GCA/TAK: * Sustained fever of \>38 C for \> 1 week * Vascular pain/tenderness \> 1 day, non-fleeting * Headache a) present \> 1 day b) non-fleeting c) not relieved with analgesics d) not typical for pre-existing headaches * Ischemic retinopathy, optic neuropathy, or visual loss * Tongue/jaw pain and/or claudication * TIA or stroke * Extremity claudication * Musculoskeletal symptoms + ESR of \> 40 mm/hr or CRP above the normal limit * Malaise/fatigue + ESR of \> 40 mm/hr or CRP above the normal limit * Other symptoms/signs due to GCA/TAK requiring reinstitution/increase in GC Imaging features • Development of new vascular stenosis or aneurysm in new vascular territories as seen by MRI/MRA or arteriogram |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Outcome - Relapse-free Survival (RFS) | Weeks 0 to 64 | The primary study endpoint was relapse-free survival (RFS). Kaplan-Meier curves of RFS were constructed for each stratum (giant cell arteritis and Takayasu arteritis), and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Outcome - Relapse-free Survival (RFS) | Group A - Abatacept in Giant Cell Arteritis | Relapsed | 10 | Participants | |
| Primary Outcome - Relapse-free Survival (RFS) | Group B - Placebo in Giant Cell Arteritis | Relapsed | 14 | Participants | |
| Primary Outcome - Relapse-free Survival (RFS) | Group C - Abatacept in Takayasu Arteritis | Relapsed | 8 | Participants | |
| Primary Outcome - Relapse-free Survival (RFS) | Group D - Placebo in Takayasu Arteritis | Relapsed | 10 | Participants | |
| Primary Outcome - Relapse-free Survival (RFS) | Group A - Abatacept in Giant Cell Arteritis | Remained in remission | 10 | Participants | |
| Primary Outcome - Relapse-free Survival (RFS) | Group B - Placebo in Giant Cell Arteritis | Remained in remission | 7 | Participants | |
| Primary Outcome - Relapse-free Survival (RFS) | Group C - Abatacept in Takayasu Arteritis | Remained in remission | 3 | Participants | |
| Primary Outcome - Relapse-free Survival (RFS) | Group D - Placebo in Takayasu Arteritis | Remained in remission | 5 | Participants |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Entry to Week 12 | STARTED | Group A - Abatacept in Giant Cell Arteritis | 49 | |
| Study Entry to Week 12 | STARTED | Group B - Placebo in Giant Cell Arteritis | 0 | |
| Study Entry to Week 12 | STARTED | Group C - Abatacept in Takayasu Arteritis | 34 | |
| Study Entry to Week 12 | STARTED | Group D - Placebo in Takayasu Arteritis | 0 | |
| Study Entry to Week 12 | COMPLETED | Group A - Abatacept in Giant Cell Arteritis | 41 | |
| Study Entry to Week 12 | COMPLETED | Group B - Placebo in Giant Cell Arteritis | 0 | |
| Study Entry to Week 12 | COMPLETED | Group C - Abatacept in Takayasu Arteritis | 26 | |
| Study Entry to Week 12 | COMPLETED | Group D - Placebo in Takayasu Arteritis | 0 | |
| Study Entry to Week 12 | NOT COMPLETED | Group A - Abatacept in Giant Cell Arteritis | 8 | |
| Study Entry to Week 12 | NOT COMPLETED | Group B - Placebo in Giant Cell Arteritis | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events384
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 | Blood and bone marrow - other | Blood and lymphatic system disorders | Group A - Abatacept in Giant Cell Arteritis | 1 | 20 | 1 |
| other | Blood and bone marrow - other | Blood and lymphatic system disorders | Group B - Placebo in Giant Cell Arteritis | 0 | 21 | 0 |
| other | Blood and bone marrow - other | Blood and lymphatic system disorders | Group C - Abatacept in Takayasu Arteritis | 0 | 11 | 0 |
| other | Blood and bone marrow - other | Blood and lymphatic system disorders | Group D - Placebo in Takayasu Arteritis | 0 | 15 | 0 |
| other | Hemoglobin | Blood and lymphatic system disorders | Group A - Abatacept in Giant Cell Arteritis | 3 | 20 | 4 |
| other | Hemoglobin | Blood and lymphatic system disorders | Group B - Placebo in Giant Cell Arteritis | 2 | 21 | 3 |
| other | Hemoglobin | Blood and lymphatic system disorders | Group C - Abatacept in Takayasu Arteritis | 0 | 11 | 0 |
| other | Hemoglobin | Blood and lymphatic system disorders | Group D - Placebo in Takayasu Arteritis | 0 | 15 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Group A - Abatacept in Giant Cell Arteritis | 1 | 20 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Group B - Placebo in Giant Cell Arteritis | 0 | 21 | 0 |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A - Abatacept in Giant Cell Arteritis | 0 | 20 |
| Total, all-cause mortality | Group B - Placebo in Giant Cell Arteritis | 0 | 21 |
| Total, all-cause mortality | Group C - Abatacept in Takayasu Arteritis | 0 | 11 |
| Total, all-cause mortality | Group D - Placebo in Takayasu Arteritis | 0 | 15 |
| Total, other adverse events | Group A - Abatacept in Giant Cell Arteritis | 14 | 20 |
| Total, other adverse events | Group B - Placebo in Giant Cell Arteritis | 15 | 21 |
| Total, other adverse events | Group C - Abatacept in Takayasu Arteritis | 8 | 11 |
| Total, other adverse events | Group D - Placebo in Takayasu Arteritis | 14 | 15 |
| Total, serious adverse events | Group A - Abatacept in Giant Cell Arteritis | 8 | 20 |
| Total, serious adverse events | Group B - Placebo in Giant Cell Arteritis | 5 | 21 |
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/NCT00556439
GET https://conductscience.org/api/trials/v1/NCT00556439/flow?page=2