| ID | Type | Description | Link |
|---|---|---|---|
| 268200700036C-5-0-1 | U.S. NIH Grant/Contract | View source | |
| HHSN2682007000036C |
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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
| Office of Rare Diseases (ORD) | NIH |
| Rare Diseases Clinical Research Network | NETWORK |
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Giant cell arteritis (GCA) and Takayasu's arteritis (TAK) are diseases that cause swelling of the arteries in the head, neck, upper body, and arms. TAK specifically affects the aorta, the largest blood vessel in the body, and its branches. Therapies are available to improve the symptoms of GCA and TAK, but relapse often occurs, and better treatments are needed. Abatacept is a drug that interacts with certain cells in the body that are involved with GCA and TAK. This study will evaluate the effectiveness of abatacept in treating GCA and TAK and preventing disease relapse.
GCA and TAK both cause inflammation in the lining of the arteries, which can interfere with the body's ability to carry oxygen to areas that need it. Symptoms of GCA include headaches, jaw pain, and blurred or double vision. Serious symptoms that occur less commonly are blindness and stroke. TAK symptoms include fever, fatigue, weight loss, arthritis, and non-specific aches and pains. There may also be tenderness near affected arteries. Researchers believe that GCA and TAK are diseases that are controlled by the body's immune system. Activated T-cells, specifically, are critical to the origin and development of these diseases. Abatacept is a medication that modulates the signal required for T-cell activation. This study will evaluate the safety and effectiveness of abatacept in treating GCA and TAK and preventing disease relapse.
Participation in this study may last up to 4 years. Participants will receive abatacept intravenously on specified days during Months 1, 2, and 3. They will also receive daily prednisone, which will be started at a dose of 40 to 60mg, then tapered to 20mg by Month 3, and finally further tapered until discontinuation is reached. At Month 3, participants who have achieved remission will be randomly assigned under double-blind conditions to either continue abatacept or be switched to placebo infusions. Both treatments will be given once a month at study visits. Blood samples will also be collected at the monthly study visits to conduct laboratory-based studies. Participants who remain in remission will continue to receive abatacept or placebo monthly until the common closing date, defined as 12 months after enrollment of the 33rd participant for each disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A and C | Experimental | This is a randomized withdrawal design protocol. All participants will receive abatacept and prednisone (a glucocorticoid) for the first 3 months. Abatacept will be given intravenously on selected days. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Month 3, and finally further tapered until discontinuation is reached. At Month 3, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A for giant cell arteritis and Group C for Takayasu arteritis. |
|
| B and D | Placebo Comparator | This is a randomized withdrawal design protocol. All participants will receive abatacept and prednisone (a glucocorticoid) for the first 3 months. Abatacept will be given intravenously on selected days. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Month 3, and finally further tapered until discontinuation is reached. At Month 3, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B for giant cell arteritis and Group D for Takayasu arteritis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | Participants will receive a fixed dose of abatacept, approximating 10mg per kilogram of body weight. The following dosing rules will be followed:
Abatacept will be administered in a 30-minute intravenous infusion on Days 1, 15, 29 (Month 1) and at Month 2. In the absence of toxicity or relapse, participants will remain on abatacept at the same dosage until randomization at Month 3. After randomization, only Group A (giant cell arteritis) and Group C (Takayasu arteritis) participants will continue on abatacept. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome - Relapse-free Survival (RFS) | 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:
Imaging features • Development of new vascular stenosis or aneurysm in new vascular territories as seen by MRI/MRA or arteriogram | Weeks 0 to 64 |
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Inclusion Criteria:
Specific Inclusion Criteria for Participants with GCA:
Participants must meet three of the following five criteria, including either Criterion 4 or 5:
Specific Inclusion Criteria for Participants with TAK:
Presence of abnormalities that are consistent with TAK identified using arteriography, plus at least one of the following criteria:
Exclusion Criteria:
Evidence of active infection (including chronic infection)
Pregnant or breastfeeding
HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen
Inability to comply with study guidelines
Inability to provide informed consent
Cytopenia, as defined by a platelet count of less than 80,000/mm3, an absolute neutrophil count of less than 1,500/mm3, and hematocrit less than 20%
Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less
Other uncontrolled disease that could prevent safe study completion
History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin or solid tumors treated with curative therapy and disease-free for at least 5 years
Receipt of an investigational agent or device within 30 days prior to study entry
A live vaccination within 4 weeks prior to study entry
Presence of a positive tuberculin skin test with induration of at least 5mm
Radiographic evidence suggestive of tuberculosis
Poor tolerability of blood draws or lack of adequate access to veins for medication administration and blood draws
History of treatment with rituximab within 12 months prior to study entry or history of treatment with rituximab more than 12 months prior to study entry, where the B lymphocyte count has not returned to normal
History of treatment with infliximab within the past 49 days, adalimumab within the past 28 days, or etanercept within the past 21 days.
Presence of any of the following diseases or conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Carol A. Langford, MD, MHS | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Johns Hopkins Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28133931 | Derived | Langford CA, Cuthbertson D, Ytterberg SR, Khalidi N, Monach PA, Carette S, Seo P, Moreland LW, Weisman M, Koening CL, Sreih AG, Spiera R, McAlear CA, Warrington KJ, Pagnoux C, McKinnon K, Forbess LJ, Hoffman GS, Borchin R, Krischer JP, Merkel PA; Vasculitis Clinical Research Consortium. A Randomized, Double-Blind Trial of Abatacept (CTLA-4Ig) for the Treatment of Takayasu Arteritis. Arthritis Rheumatol. 2017 Apr;69(4):846-853. doi: 10.1002/art.40037. Epub 2017 Mar 8. | |
| 28133925 |
| Label | URL |
|---|---|
| Click here for the Cleveland Clinic Center for Vasculitis Care and Research Web site | View source |
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Participants with giant cell arteritis or Takayasu arteritis were recruited at 11 academic medical centers. For giant cell arteritis, the first participant was enrolled 2/2009 and the last participant was enrolled 1/2014. For Takayasu arteritis, the first participant was enrolled 2/2009 and the last participant was enrolled 11/2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A - Abatacept in Giant Cell Arteritis | This is a randomized withdrawal design protocol. Participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:
At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Entry to Week 12 |
|
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| Placebo | Drug | Placebo abatacept infusions will be given monthly after random assignment at Month 3. |
|
| Baltimore |
| Maryland |
| 21224 |
| United States |
| Boston University | Boston | Massachusetts | 02118 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| St. Joseph's Hospital | Hamilton | Ontario | L8P 3B3 | Canada |
| Mt. Sinai Hospital Toronto | Toronto | Ontario | M5T 3L9 | Canada |
| Langford CA, Cuthbertson D, Ytterberg SR, Khalidi N, Monach PA, Carette S, Seo P, Moreland LW, Weisman M, Koening CL, Sreih AG, Spiera R, McAlear CA, Warrington KJ, Pagnoux C, McKinnon K, Forbess LJ, Hoffman GS, Borchin R, Krischer JP, Merkel PA; Vasculitis Clinical Research Consortium. A Randomized, Double-Blind Trial of Abatacept (CTLA-4Ig) for the Treatment of Giant Cell Arteritis. Arthritis Rheumatol. 2017 Apr;69(4):837-845. doi: 10.1002/art.40044. Epub 2017 Mar 3. |
| 24574239 | Derived | Goldstein BL, Gedmintas L, Todd DJ. Drug-associated polymyalgia rheumatica/giant cell arteritis occurring in two patients after treatment with ipilimumab, an antagonist of ctla-4. Arthritis Rheumatol. 2014 Mar;66(3):768-9. doi: 10.1002/art.38282. No abstract available. |
| FG001 | Group B - Placebo in Giant Cell Arteritis | This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:
At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B. |
| FG002 | Group C - Abatacept in Takayasu Arteritis | This is a randomized withdrawal design protocol. Participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:
At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group C. |
| FG003 | Group D - Placebo in Takayasu Arteritis | This is a randomized withdrawal design protocol. All participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:
At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group D. |
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| NOT COMPLETED |
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| After Week 12 (Randomized Study Period) |
|
|
Reflects the population that reached Week 12 blinded randomization. In the giant cell arteritis cohort, 8 of 49 were withdrawn at or before Week 12 with a total of 41 remaining in the active comparator group. In the Takayasu arteritis cohort, 8 of 34 were withdrawn at or before Week 12 with a total of 26 remaining in the active comparator group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A - Abatacept in Giant Cell Arteritis | This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:
At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A. |
| BG001 | Group B - Placebo in Giant Cell Arteritis | This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:
At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B. |
| BG002 | Group C - Abatacept in Takayasu Arteritis | This is a randomized withdrawal design protocol. All participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:
At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group C. |
| BG003 | Group D - Placebo in Takayasu Arteritis | This is a randomized withdrawal design protocol. All participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:
At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group D. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Outcome - Relapse-free Survival (RFS) | 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:
Imaging features • Development of new vascular stenosis or aneurysm in new vascular territories as seen by MRI/MRA or arteriogram | 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. | Posted | Count of Participants | Participants | Weeks 0 to 64 |
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Week 0 to end of study
Toxicity grades were assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE). Expected or unexpected adverse events that were grade 1 were not collected or reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A - Abatacept in Giant Cell Arteritis | This is a randomized withdrawal design protocol. Participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:
At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group A. | 0 | 20 | 8 | 20 | 14 | 20 |
| EG001 | Group B - Placebo in Giant Cell Arteritis | This is a randomized withdrawal design protocol. All participants with giant cell arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:
At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group B. | 0 | 21 | 5 | 21 | 15 | 21 |
| EG002 | Group C - Abatacept in Takayasu Arteritis | This is a randomized withdrawal design protocol. Participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:
At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to abatacept at this point will be in Group C. | 0 | 11 | 5 | 11 | 8 | 11 |
| EG003 | Group D - Placebo in Takayasu Arteritis | This is a randomized withdrawal design protocol. All participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:
At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group D. | 0 | 15 | 7 | 15 | 14 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular/visual - other | Eye disorders | Systematic Assessment | Branch retinal artery occlusion - 1 event, Transient vision loss - presumed due to GCA - 1 event |
| |
| Retinal detachment | Eye disorders | Systematic Assessment |
| ||
| Intraoperative-injury - other | Surgical and medical procedures | Systematic Assessment | Total knee replacement |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | Systematic Assessment | Post-operative deep venous thrombosis |
| |
| Gastrointestinal - other | Gastrointestinal disorders | Systematic Assessment | Diarrhea/dehydration |
| |
| Dermatology /Skin - other | Skin and subcutaneous tissue disorders | Systematic Assessment | Herpes zoster - 1 event - abatacept, Squamous cell carcinoma - 1 event - placebo |
| |
| Metabolic/laboratory - other | Investigations | Systematic Assessment | Hyperglycemia |
| |
| Infection with normal ANC or grade 1 or 2 neutrophils | Infections and infestations | Systematic Assessment | Diverticulitis |
| |
| Bone: spine-scoliosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Spinal surgery |
| |
| Syncope (fainting) | Nervous system disorders | Systematic Assessment | Syncope |
| |
| Pain - other | General disorders | Systematic Assessment | Narcotic withdrawal |
| |
| Pulmonary/Upper respiratory - other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dyspnea - 1 event, COPD - 1 event |
| |
| Renal/genitourinary - other | Renal and urinary disorders | Systematic Assessment | Endometrial carcinoma - 1 event Transitional cell carcinoma - 1 event |
| |
| Urinary electrolyte wasting | Renal and urinary disorders | Systematic Assessment | Urine electrolyte disturbance |
| |
| Gastrointestinal - other | Gastrointestinal disorders | Systematic Assessment | Ischemic colitis |
| |
| Ulcer - GI | Gastrointestinal disorders | Systematic Assessment | Duodenal ulcer |
| |
| Hemorrhage - GI | Gastrointestinal disorders | Systematic Assessment | Ischemic colitis - 1 event, Rectal bleeding - 1 event |
| |
| Infection - other | Infections and infestations | Systematic Assessment | Possible pyelonephritis - 1 event - abatacept, Skin site infection post thrombectomy - 1 event - abatacept, Pyelonephritis - 1 event - placebo, Epiglottitis - 1 event - placebo |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations | Systematic Assessment | Appendicitis - 1 event, Nausea/vomiting/diarrhea due to possible infection - 1 event |
| |
| Pain - other | General disorders | Systematic Assessment | Non cardiac chest pain - 6 events in 1 participant - abatacept, Headache due to Migraine - 1 event - abatacept, Chest pain unclear etiology - 1 event - placebo |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Dyspnea/dysphagia due to GERD |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | Systematic Assessment | Arterial thrombosis following angioplasty |
| |
| Vascular - other | Vascular disorders | Systematic Assessment | Elective aortic surgery |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and bone marrow - other | Blood and lymphatic system disorders | Systematic Assessment |
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| Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Cardiac arrhythmia - other | Cardiac disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Vasovagal episode | Cardiac disorders | Systematic Assessment |
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| Cardiac ischemia/infarction | Cardiac disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
| ||
| Insomnia | General disorders | Systematic Assessment |
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| Weight gain | General disorders | Systematic Assessment |
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| Weight loss | General disorders | Systematic Assessment |
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| Dermatology - other | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Adrenal insufficiency | Endocrine disorders | Systematic Assessment |
| ||
| Endocrine - other | Endocrine disorders | Systematic Assessment |
| ||
| Hot flashes/flushes | Endocrine disorders | Systematic Assessment |
| ||
| Hypothyroid | Endocrine disorders | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal - other | Gastrointestinal disorders | Systematic Assessment |
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| Heartburn/dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Infection - other | Infections and infestations | Systematic Assessment |
| ||
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations | Systematic Assessment |
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| Infection with unknown ANC | Infections and infestations | Systematic Assessment |
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| ALT, SGPT | Investigations | Systematic Assessment |
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| AST, SGOT | Investigations | Systematic Assessment |
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| Metabolic/laboratory - other | Investigations | Systematic Assessment |
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| Arthritis non-septic | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Joint - function | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal/Soft tissue - other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Memory impairment | Nervous system disorders | Systematic Assessment |
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| Mood alteration | Nervous system disorders | Systematic Assessment |
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| Cataract | Eye disorders | Systematic Assessment |
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| Ocular/Visual - other | Eye disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Pain - other | General disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary/Upper respiratory - other | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Renal/Genitourinary - other | Renal and urinary disorders | Systematic Assessment |
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| Allergic reaction/hypersensitivity | Immune system disorders | Systematic Assessment |
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| Vasculitis | Immune system disorders | Systematic Assessment |
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| Hearing | Ear and labyrinth disorders | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cardiac general - other | Cardiac disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Weight gain | General disorders | Systematic Assessment |
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| Dermatology/skin - other | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Endocrine - other | Endocrine disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Infection - other | Infections and infestations | Systematic Assessment |
| ||
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations | Systematic Assessment |
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| Infection with unknown ANC | Infections and infestations | Systematic Assessment |
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| Edema: limb | Blood and lymphatic system disorders | Systematic Assessment |
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| AST, SGOT | Investigations | Systematic Assessment |
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| Albumin, serum - low | Investigations | Systematic Assessment |
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| Calcium, serum - low | Investigations | Systematic Assessment |
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| Glucose, serum - high | Investigations | Systematic Assessment |
| ||
| Glucose, serum - low | Investigations | Systematic Assessment |
| ||
| Metabolic/laboratory - other | Investigations | Systematic Assessment |
| ||
| Sodium, serum - low | Investigations | Systematic Assessment |
| ||
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Mood alteration | Nervous system disorders | Systematic Assessment |
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| Neurology - other | Nervous system disorders | Systematic Assessment |
| ||
| Ocular/visual - other | Eye disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pain - other | General disorders | Systematic Assessment |
| ||
| Vascular - other | Vascular disorders | Systematic Assessment |
|
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.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carol A Langford, MD MHS | Cleveland Clinic | 216-445-6056 | langfoc@ccf.org |
| ID | Term |
|---|---|
| D013625 | Takayasu Arteritis |
| D013700 | Giant Cell Arteritis |
| D014657 | Vasculitis |
| D001167 | Arteritis |
| ID | Term |
|---|---|
| D001015 | Aortic Arch Syndromes |
| D001018 | Aortic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
Not provided
Not provided
| Physician Decision |
|
| Malignancy |
|
| Severe infection |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| OG003 | Group D - Placebo in Takayasu Arteritis | This is a randomized withdrawal design protocol. Participants with Takayasu arteritis will receive prednisone (a glucocorticoid) and abatacept for the first 12 weeks. Prednisone will be started at a dose of 40 to 60mg, then tapered to 20mg by Week 12 and finally further tapered until discontinuation is reached at Week 28. Abatacept will be given intravenously on Day 1, Day 15, and Week 8 at a fixed dose approximating 10mg per kilogram of body weight. The following dosing rules for abatacept will be followed:
At Week 12, participants who have achieved remission will be randomly assigned under double-blind conditions to receive monthly infusions of either abatacept or placebo. Participants who are assigned to placebo at this point will be in Group D. |
| Remained in remission |
|
Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.
| The planned sample size was determined by the minimally clinically meaningful result (i.e., an approximate 30% improvement in relapse-free survival) to be detected utilizing a one-sided alpha of 0.1. Kaplan-Meier curves of RFS were constructed for each stratum, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat. | Log Rank | 0.853 | The p value of 0.853 reflects comparison of relapse free survival of abatacept versus placebo in Takayasu arteritis. | Other | Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat. |