Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 89 of 137 for:    "Connective Tissue Disease" | "Abatacept"

Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00556439
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Collaborators:
The Cleveland Clinic
Office of Rare Diseases (ORD)
Rare Diseases Clinical Research Network
Information provided by (Responsible Party):
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Takayasu's Arteritis
Giant Cell Arteritis
Interventions Drug: Abatacept
Drug: Placebo
Enrollment 97
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Group A - Abatacept in Giant Cell Arteritis Group B - Placebo in Giant Cell Arteritis Group C - Abatacept in Takayasu Arteritis Group D - Placebo in Takayasu Arteritis
Hide Arm/Group Description

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

Period Title: Study Entry to Week 12
Started 49 [1] 0 [2] 34 [3] 0 [2]
Completed 41 0 26 0
Not Completed 8 0 8 0
Reason Not Completed
Lack of Efficacy             5             0             6             0
Physician Decision             1             0             0             0
Withdrawal by Subject             1             0             1             0
Recurrent infection             1             0             0             0
Malignancy             0             0             1             0
[1]
58 signed informed consent with 9 not being eligible. The remaining 49 received study drug.
[2]
No participants received placebo until the Week 12 Randomization
[3]
39 signed informed consent with 5 not being eligible. The remaining 34 received study drug.
Period Title: After Week 12 (Randomized Study Period)
Started 20 21 11 15
Completed 17 17 11 14
Not Completed 3 4 0 1
Reason Not Completed
Withdrawal by Subject             1             3             0             0
Physician Decision             1             0             0             0
Malignancy             0             1             0             1
Severe infection             1             0             0             0
Arm/Group Title Group A - Abatacept in Giant Cell Arteritis Group B - Placebo in Giant Cell Arteritis Group C - Abatacept in Takayasu Arteritis Group D - Placebo in Takayasu Arteritis Total
Hide Arm/Group Description

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

Total of all reporting groups
Overall Number of Baseline Participants 20 21 11 15 67
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 11 participants 15 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  55.0%
3
  14.3%
11
 100.0%
15
 100.0%
40
  59.7%
>=65 years
9
  45.0%
18
  85.7%
0
   0.0%
0
   0.0%
27
  40.3%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 11 participants 15 participants 67 participants
63.47
(57.27 to 80.13)
71.48
(54.26 to 86.63)
30.17
(18.93 to 58.94)
28.61
(19.54 to 56.97)
48.74
(19.93 to 86.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 11 participants 15 participants 67 participants
Female
16
  80.0%
21
 100.0%
9
  81.8%
13
  86.7%
59
  88.1%
Male
4
  20.0%
0
   0.0%
2
  18.2%
2
  13.3%
8
  11.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 11 participants 15 participants 67 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
1
   1.5%
Not Hispanic or Latino
17
  85.0%
21
 100.0%
10
  90.9%
14
  93.3%
62
  92.5%
Unknown or Not Reported
3
  15.0%
0
   0.0%
0
   0.0%
1
   6.7%
4
   6.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 11 participants 15 participants 67 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   4.8%
1
   9.1%
3
  20.0%
5
   7.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.0%
1
   4.8%
1
   9.1%
0
   0.0%
3
   4.5%
White
19
  95.0%
19
  90.5%
8
  72.7%
12
  80.0%
58
  86.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
1
   1.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 11 participants 15 participants 67 participants
Canada 6 5 3 3 17
United States 14 16 8 12 50
1.Primary Outcome
Title Primary Outcome - Relapse-free Survival (RFS)
Hide Description

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

Time Frame Weeks 0 to 64
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group A - Abatacept in Giant Cell Arteritis Group B - Placebo in Giant Cell Arteritis Group C - Abatacept in Takayasu Arteritis Group D - Placebo in Takayasu Arteritis
Hide Arm/Group Description:

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

Overall Number of Participants Analyzed 20 21 11 15
Measure Type: Count of Participants
Unit of Measure: Participants
Relapsed
10
  50.0%
14
  66.7%
8
  72.7%
10
  66.7%
Remained in remission
10
  50.0%
7
  33.3%
3
  27.3%
5
  33.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Abatacept in Giant Cell Arteritis, Group B - Placebo in Giant Cell Arteritis
Comments 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.
Type of Statistical Test Other
Comments 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.
Statistical Test of Hypothesis P-Value 0.049
Comments The p value of 0.049 reflects comparison of relapse free survival of abatacept versus placebo in giant cell arteritis.
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group C - Abatacept in Takayasu Arteritis, Group D - Placebo in Takayasu Arteritis
Comments 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.
Type of Statistical Test Other
Comments 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.
Statistical Test of Hypothesis P-Value 0.853
Comments The p value of 0.853 reflects comparison of relapse free survival of abatacept versus placebo in Takayasu arteritis.
Method Log Rank
Comments [Not Specified]
Time Frame Week 0 to end of study
Adverse Event Reporting Description 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.
 
Arm/Group Title Group A - Abatacept in Giant Cell Arteritis Group B - Placebo in Giant Cell Arteritis Group C - Abatacept in Takayasu Arteritis Group D - Placebo in Takayasu Arteritis
Hide Arm/Group Description

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

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:

  • Participants weighing less than 60kg will receive 500mg of abatacept.
  • Participants weighing 60 to 100kg will receive 750mg of abatacept.
  • Participants weighing more than 100kg will receive 1000mg of abatacept.

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.

All-Cause Mortality
Group A - Abatacept in Giant Cell Arteritis Group B - Placebo in Giant Cell Arteritis Group C - Abatacept in Takayasu Arteritis Group D - Placebo in Takayasu Arteritis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/21 (0.00%)      0/11 (0.00%)      0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group A - Abatacept in Giant Cell Arteritis Group B - Placebo in Giant Cell Arteritis Group C - Abatacept in Takayasu Arteritis Group D - Placebo in Takayasu Arteritis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/20 (40.00%)      5/21 (23.81%)      5/11 (45.45%)      7/15 (46.67%)    
Eye disorders         
Ocular/visual - other  [1]  2/20 (10.00%)  2 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Retinal detachment   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Gastrointestinal disorders         
Gastrointestinal - other  [2]  1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Gastrointestinal - other  [3]  0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 1/15 (6.67%)  1
Ulcer - GI  [4]  0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 0/15 (0.00%)  0
Hemorrhage - GI  [5]  0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 2/15 (13.33%)  2
General disorders         
Pain - other  [6]  0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Pain - other  [7]  0/20 (0.00%)  0 0/21 (0.00%)  0 2/11 (18.18%)  7 1/15 (6.67%)  1
Infections and infestations         
Infection with normal ANC or grade 1 or 2 neutrophils  [8]  1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Infection - other  [9]  0/20 (0.00%)  0 0/21 (0.00%)  0 2/11 (18.18%)  2 2/15 (13.33%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils  [10]  0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 2/15 (13.33%)  2
Investigations         
Metabolic/laboratory - other  [11]  0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Bone: spine-scoliosis  [12]  0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Nervous system disorders         
Syncope (fainting)  [13]  0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Renal and urinary disorders         
Renal/genitourinary - other  [14]  2/20 (10.00%)  2 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Urinary electrolyte wasting  [15]  0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Pulmonary/Upper respiratory - other  [16]  0/20 (0.00%)  0 2/21 (9.52%)  2 0/11 (0.00%)  0 0/15 (0.00%)  0
Dyspnea  [17]  0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 1/15 (6.67%)  1
Skin and subcutaneous tissue disorders         
Dermatology /Skin - other  [18]  1/20 (5.00%)  1 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Surgical and medical procedures         
Intraoperative-injury - other  [19]  1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Vascular disorders         
Thrombosis/thrombus/embolism  [20]  1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Thrombosis/thrombus/embolism  [21]  0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 0/15 (0.00%)  0
Vascular - other  [22]  0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 0/15 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Branch retinal artery occlusion - 1 event, Transient vision loss - presumed due to GCA - 1 event
[2]
Diarrhea/dehydration
[3]
Ischemic colitis
[4]
Duodenal ulcer
[5]
Ischemic colitis - 1 event, Rectal bleeding - 1 event
[6]
Narcotic withdrawal
[7]
Non cardiac chest pain - 6 events in 1 participant - abatacept, Headache due to Migraine - 1 event - abatacept, Chest pain unclear etiology - 1 event - placebo
[8]
Diverticulitis
[9]
Possible pyelonephritis - 1 event - abatacept, Skin site infection post thrombectomy - 1 event - abatacept, Pyelonephritis - 1 event - placebo, Epiglottitis - 1 event - placebo
[10]
Appendicitis - 1 event, Nausea/vomiting/diarrhea due to possible infection - 1 event
[11]
Hyperglycemia
[12]
Spinal surgery
[13]
Syncope
[14]
Endometrial carcinoma - 1 event Transitional cell carcinoma - 1 event
[15]
Urine electrolyte disturbance
[16]
Dyspnea - 1 event, COPD - 1 event
[17]
Dyspnea/dysphagia due to GERD
[18]
Herpes zoster - 1 event - abatacept, Squamous cell carcinoma - 1 event - placebo
[19]
Total knee replacement
[20]
Post-operative deep venous thrombosis
[21]
Arterial thrombosis following angioplasty
[22]
Elective aortic surgery
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A - Abatacept in Giant Cell Arteritis Group B - Placebo in Giant Cell Arteritis Group C - Abatacept in Takayasu Arteritis Group D - Placebo in Takayasu Arteritis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/20 (70.00%)      15/21 (71.43%)      8/11 (72.73%)      14/15 (93.33%)    
Blood and lymphatic system disorders         
Blood and bone marrow - other   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Hemoglobin   3/20 (15.00%)  4 2/21 (9.52%)  3 0/11 (0.00%)  0 0/15 (0.00%)  0
Lymphopenia   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Hemoglobin   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 1/15 (6.67%)  1
Edema: limb   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 0/15 (0.00%)  0
Cardiac disorders         
Cardiac arrhythmia - other   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Palpitations   0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Vasovagal episode   0/20 (0.00%)  0 1/21 (4.76%)  3 0/11 (0.00%)  0 0/15 (0.00%)  0
Cardiac ischemia/infarction   0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Hypertension   2/20 (10.00%)  2 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Cardiac general - other   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 1/15 (6.67%)  1
Hypertension   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 1/15 (6.67%)  1
Ear and labyrinth disorders         
Hearing   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 0/15 (0.00%)  0
Tinnitus   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 0/15 (0.00%)  0
Endocrine disorders         
Adrenal insufficiency   1/20 (5.00%)  1 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Endocrine - other   1/20 (5.00%)  1 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Hot flashes/flushes   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Hypothyroid   0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Endocrine - other   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 0/15 (0.00%)  0
Eye disorders         
Cataract   1/20 (5.00%)  2 2/21 (9.52%)  2 0/11 (0.00%)  0 0/15 (0.00%)  0
Ocular/Visual - other   1/20 (5.00%)  2 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Ocular/visual - other   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 0/15 (0.00%)  0
Gastrointestinal disorders         
Colitis   0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Constipation   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Dysphagia   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Gastrointestinal - other   1/20 (5.00%)  1 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Heartburn/dyspepsia   0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Nausea   0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 1/15 (6.67%)  1
Vomiting   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 0/15 (0.00%)  0
General disorders         
Fatigue   0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Insomnia   0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Weight gain   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Weight loss   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Pain   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Pain - other   1/20 (5.00%)  4 1/21 (4.76%)  1 0/11 (0.00%)  0/15 (0.00%)  0
Weight gain   0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 3/15 (20.00%)  3
Pain   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 1/15 (6.67%)  1
Pain - other   0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 1/15 (6.67%)  1
Immune system disorders         
Allergic reaction/hypersensitivity   0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 1/15 (6.67%)  1
Vasculitis   0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 1/15 (6.67%)  1
Infections and infestations         
Infection - other   5/20 (25.00%)  10 7/21 (33.33%)  10 0/11 (0.00%)  0 0/15 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils   2/20 (10.00%)  3 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Infection with unknown ANC   1/20 (5.00%)  2 2/21 (9.52%)  3 0/11 (0.00%)  0 0/15 (0.00%)  0
Infection - other   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  5 7/15 (46.67%)  17
Infection with normal ANC or Grade 1 or 2 neutrophils   0/20 (0.00%)  0 0/21 (0.00%)  0 3/11 (27.27%)  3 2/15 (13.33%)  9
Infection with unknown ANC   0/20 (0.00%)  0 0/21 (0.00%)  0 2/11 (18.18%)  3 2/15 (13.33%)  6
Investigations         
ALT, SGPT   2/20 (10.00%)  2 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
AST, SGOT   1/20 (5.00%)  1 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Metabolic/laboratory - other   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
AST, SGOT   0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 2/15 (13.33%)  2
Albumin, serum - low   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 0/15 (0.00%)  0
Calcium, serum - low   0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 1/15 (6.67%)  1
Glucose, serum - high   0/20 (0.00%)  0 0/21 (0.00%)  0 2/11 (18.18%)  2 0/15 (0.00%)  0
Glucose, serum - low   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 2/15 (13.33%)  4
Metabolic/laboratory - other   0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 1/15 (6.67%)  1
Sodium, serum - low   0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders         
Arthritis non-septic   0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Fracture   2/20 (10.00%)  2 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Joint - function   0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Musculoskeletal/Soft tissue - other   2/20 (10.00%)  5 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Fracture   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 0/15 (0.00%)  0
Nervous system disorders         
Memory impairment   0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Mood alteration   1/20 (5.00%)  2 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Dizziness   0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 1/15 (6.67%)  1
Mood alteration   0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 1/15 (6.67%)  1
Neurology - other   0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 1/15 (6.67%)  1
Renal and urinary disorders         
Renal/Genitourinary - other   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnea   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Pulmonary/Upper respiratory - other   1/20 (5.00%)  1 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatology - other   3/20 (15.00%)  4 0/21 (0.00%)  0 0/11 (0.00%)  0 0/15 (0.00%)  0
Ulceration   0/20 (0.00%)  0 1/21 (4.76%)  1 0/11 (0.00%)  0 0/15 (0.00%)  0
Dermatology/skin - other   0/20 (0.00%)  0 0/21 (0.00%)  0 1/11 (9.09%)  1 2/15 (13.33%)  2
Vascular disorders         
Vascular - other   0/20 (0.00%)  0 0/21 (0.00%)  0 0/11 (0.00%)  0 1/15 (6.67%)  1
Indicates events were collected by 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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Carol A Langford, MD MHS
Organization: Cleveland Clinic
Phone: 216-445-6056
Responsible Party: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00556439     History of Changes
Obsolete Identifiers: NCT00788268
Other Study ID Numbers: N01 AR070018
268200700036C-5-0-1 ( U.S. NIH Grant/Contract )
HHSN2682007000036C
First Submitted: November 9, 2007
First Posted: November 12, 2007
Results First Submitted: April 25, 2017
Results First Posted: February 26, 2018
Last Update Posted: February 26, 2018