Trial Outcomes & Findings for Abatacept for Treating Adults With Giant Cell Arteritis and Takayasu's Arteritis (NCT NCT00556439)

Last Updated: 2018-02-26

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

97 participants

Primary outcome timeframe

Weeks 0 to 64

Results posted on

2018-02-26

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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: * 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.	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: * 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.	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: * 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.	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: * 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.
Study Entry to Week 12 STARTED	49	0	34	0
Study Entry to Week 12 COMPLETED	41	0	26	0
Study Entry to Week 12 NOT COMPLETED	8	0	8	0
After Week 12 (Randomized Study Period) STARTED	20	21	11	15
After Week 12 (Randomized Study Period) COMPLETED	17	17	11	14
After Week 12 (Randomized Study Period) NOT COMPLETED	3	4	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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: * 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.	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: * 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.	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: * 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.	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: * 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.
Study Entry to Week 12 Lack of Efficacy	5	0	6	0
Study Entry to Week 12 Physician Decision	1	0	0	0
Study Entry to Week 12 Withdrawal by Subject	1	0	1	0
Study Entry to Week 12 Recurrent infection	1	0	0	0
Study Entry to Week 12 Malignancy	0	0	1	0
After Week 12 (Randomized Study Period) Withdrawal by Subject	1	3	0	0
After Week 12 (Randomized Study Period) Physician Decision	1	0	0	0
After Week 12 (Randomized Study Period) Malignancy	0	1	0	1
After Week 12 (Randomized Study Period) Severe infection	1	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A - Abatacept in Giant Cell Arteritis n=20 Participants 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.	Group B - Placebo in Giant Cell Arteritis n=21 Participants 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.	Group C - Abatacept in Takayasu Arteritis n=11 Participants 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.	Group D - Placebo in Takayasu Arteritis n=15 Participants 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 n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants	15 Participants n=4 Participants	40 Participants n=21 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	18 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	27 Participants n=21 Participants
Age, Continuous	63.47 Years n=5 Participants	71.48 Years n=7 Participants	30.17 Years n=5 Participants	28.61 Years n=4 Participants	48.74 Years n=21 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	21 Participants n=7 Participants	9 Participants n=5 Participants	13 Participants n=4 Participants	59 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	21 Participants n=7 Participants	10 Participants n=5 Participants	14 Participants n=4 Participants	62 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	19 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants	58 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment Canada	6 participants n=5 Participants	5 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	17 participants n=21 Participants
Region of Enrollment United States	14 participants n=5 Participants	16 participants n=7 Participants	8 participants n=5 Participants	12 participants n=4 Participants	50 participants n=21 Participants

PRIMARY outcome

Timeframe: Weeks 0 to 64

Population: 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.

Outcome measures

Outcome measures
Measure	Group A - Abatacept in Giant Cell Arteritis n=20 Participants 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.	Group B - Placebo in Giant Cell Arteritis n=21 Participants 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.	Group C - Abatacept in Takayasu Arteritis n=11 Participants 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.	Group D - Placebo in Takayasu Arteritis n=15 Participants 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.
Primary Outcome - Relapse-free Survival (RFS) Relapsed	10 Participants	14 Participants	8 Participants	10 Participants
Primary Outcome - Relapse-free Survival (RFS) Remained in remission	10 Participants	7 Participants	3 Participants	5 Participants

Adverse Events

Group A - Abatacept in Giant Cell Arteritis

Serious events: 8 serious events

Other events: 14 other events

Deaths: 0 deaths

Group B - Placebo in Giant Cell Arteritis

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Group C - Abatacept in Takayasu Arteritis

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Group D - Placebo in Takayasu Arteritis

Serious events: 7 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Carol A Langford, MD MHS

Cleveland Clinic

Phone: 216-445-6056

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Group A - Abatacept in Giant Cell Arteritis n=20 participants at risk 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.	Group B - Placebo in Giant Cell Arteritis n=21 participants at risk 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.	Group C - Abatacept in Takayasu Arteritis n=11 participants at risk 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.	Group D - Placebo in Takayasu Arteritis n=15 participants at risk 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.
Blood and lymphatic system disorders Blood and bone marrow - other	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Blood and lymphatic system disorders Hemoglobin	0.00% 0/20 • 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.	0.00% 0/21 • 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.	9.1% 1/11 • Number of events 1 • 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.	6.7% 1/15 • Number of events 1 • 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.
Blood and lymphatic system disorders Lymphopenia	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Cardiac disorders Cardiac arrhythmia - other	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Cardiac disorders Palpitations	0.00% 0/20 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Cardiac disorders Vasovagal episode	0.00% 0/20 • 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.	4.8% 1/21 • Number of events 3 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Cardiac disorders Cardiac ischemia/infarction	0.00% 0/20 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Cardiac disorders Hypertension	0.00% 0/20 • 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.	0.00% 0/21 • 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.	9.1% 1/11 • Number of events 1 • 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.	6.7% 1/15 • Number of events 1 • 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.
General disorders Fatigue	0.00% 0/20 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
General disorders Insomnia	0.00% 0/20 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
General disorders Weight gain	0.00% 0/20 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	20.0% 3/15 • Number of events 3 • 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.
General disorders Weight loss	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Skin and subcutaneous tissue disorders Dermatology - other	15.0% 3/20 • Number of events 4 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Skin and subcutaneous tissue disorders Ulceration	0.00% 0/20 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Endocrine disorders Adrenal insufficiency	5.0% 1/20 • Number of events 1 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Endocrine disorders Endocrine - other	0.00% 0/20 • 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.	0.00% 0/21 • 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.	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/15 • 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.
Endocrine disorders Hot flashes/flushes	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Endocrine disorders Hypothyroid	0.00% 0/20 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Gastrointestinal disorders Colitis	0.00% 0/20 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Gastrointestinal disorders Constipation	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Gastrointestinal disorders Dysphagia	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Gastrointestinal disorders Gastrointestinal - other	5.0% 1/20 • Number of events 1 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Gastrointestinal disorders Heartburn/dyspepsia	0.00% 0/20 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Infections and infestations Infection - other	0.00% 0/20 • 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.	0.00% 0/21 • 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.	9.1% 1/11 • Number of events 5 • 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.	46.7% 7/15 • Number of events 17 • 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.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils	0.00% 0/20 • 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.	0.00% 0/21 • 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.	27.3% 3/11 • Number of events 3 • 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.	13.3% 2/15 • Number of events 9 • 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.
Infections and infestations Infection with unknown ANC	0.00% 0/20 • 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.	0.00% 0/21 • 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.	18.2% 2/11 • Number of events 3 • 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.	13.3% 2/15 • Number of events 6 • 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.
Investigations ALT, SGPT	10.0% 2/20 • Number of events 2 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Investigations AST, SGOT	0.00% 0/20 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	13.3% 2/15 • Number of events 2 • 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.
Investigations Metabolic/laboratory - other	0.00% 0/20 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	6.7% 1/15 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Arthritis non-septic	0.00% 0/20 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Musculoskeletal and connective tissue disorders Fracture	0.00% 0/20 • 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.	0.00% 0/21 • 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.	9.1% 1/11 • Number of events 1 • 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.	0.00% 0/15 • 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.
Musculoskeletal and connective tissue disorders Joint - function	0.00% 0/20 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft tissue - other	10.0% 2/20 • Number of events 5 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Nervous system disorders Memory impairment	0.00% 0/20 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Nervous system disorders Mood alteration	0.00% 0/20 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	6.7% 1/15 • Number of events 1 • 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.
Eye disorders Cataract	5.0% 1/20 • Number of events 2 • 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.	9.5% 2/21 • Number of events 2 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
Eye disorders Ocular/Visual - other	5.0% 1/20 • Number of events 2 • 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.	4.8% 1/21 • Number of events 1 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.
General disorders Pain	0.00% 0/20 • 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.	0.00% 0/21 • 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.	9.1% 1/11 • Number of events 1 • 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.	6.7% 1/15 • Number of events 1 • 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.
General disorders Pain - other	0.00% 0/20 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	6.7% 1/15 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.0% 1/20 • Number of events 1 • 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.	0.00% 0/21 • 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.	0.00% 0/11 • 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.	0.00% 0/15 • 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.