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Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)

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ClinicalTrials.gov Identifier: NCT00254293
Recruitment Status : Completed
First Posted : November 16, 2005
Results First Posted : April 8, 2014
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Abatacept or Placebo (both as IV & SC Solution)
Drug: Abatacept or Placebo (both as IV & SC solution)
Drug: Abatacept
Enrollment 87
Recruitment Details Short term (12 week) randomized Period: started January 2006/completed May 2007. Long term extension (LTE): started April 2006/completed July 2012. During LTE: variable dose period and fixed dose period. Patients with active Rheumatoid Arthritis (RA) and receiving disease modifying anti-rheumatic drugs (DMARDS) were eligible to participate.
Pre-assignment Details Enrolled/not treated (19): prior treatment not washed out; no longer met study criteria; withdrew consent before treatment. To enter LTE, participant completed the short term period, and was assigned to a variable SC dose group (75, 125, 200 mg SC abatacept) based on body weight; completers of variable dose LTE rolled over into fixed dose LTE.
Arm/Group Title Group 1: 500 mg IV/75 mg SC Group 2: 500 mg IV/125 mg SC Group 3 : 750 mg IV/125 mg SC Group 4: 1000mg IV/125 mg SC Group 5: 1000 mg IV/200 mg SC Placebo Fixed Dose 125 mg Abatacept
Hide Arm/Group Description Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); body weight < 60 kg. Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo;body weight < 60 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight <60 to >100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo (body weight 60-100 kg). Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight <60 to >100 kg). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period. Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo; Body weight > 100 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period); variable long term for 125 mg SC: body weight <60 to >100 kg) . Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period. Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo; body weight > 100 kg. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), by body weight. Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period Participants who completed the variable dose long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (75, 125, 200 mg SC) were rolled over into the LTE with fixed dose, irrespective of body weight: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
Period Title: Short Term (12 Week) Randomized Dosing
Started 7 4 29 6 5 17 [1] 0
Completed 7 3 26 5 5 17 0
Not Completed 0 1 3 1 0 0 0
Reason Not Completed
Adverse Event             0             1             0             1             0             0             0
Lost to Follow-up             0             0             1             0             0             0             0
poor/non-compliance by participant             0             0             2             0             0             0             0
[1]
2, 2, 9, 2, and 2 were randomized to placebo in body weight Groups 1, 2, 3, 4, 5, respectively.
Period Title: LTE Open Label Variable SC Dosing
Started 11 [1] 0 [2] 42 [3] 0 [2] 10 [4] 0 [5] 0 [6]
Completed 8 0 32 0 8 0 0
Not Completed 3 0 10 0 2 0 0
Reason Not Completed
Death             0             0             1             0             0             0             0
Adverse Event             1             0             2             0             1             0             0
Lack of Efficacy             2             0             2             0             1             0             0
Lost to Follow-up             0             0             1             0             0             0             0
Withdrawal by Subject             0             0             1             0             0             0             0
Poor or non-compliance             0             0             1             0             0             0             0
not specified             0             0             2             0             0             0             0
[1]
Participants who received ST placebo rolled over to 75mg SC dose group (by body weight, <60kg).
[2]
Participants rolled over to 125mg dose group summarized as one group (body weight <60 to >100 kg).
[3]
Variable SC dose group: 125 mg Weekly, body weight <60 to >100kg (Groups 2, 3, 4 in ST Period).
[4]
Participants who received ST placebo rolled over to variable SC dose group (by body weight, >100kg).
[5]
Participants rolled over to a variable SC dose group of 75, 125 or 200 mg Weekly by body weight.
[6]
Participant rolled over from LTE (Variable Dose Period) to LTE (Fixed Dose Period).
Period Title: LTE Open Label Fixed Dosing
Started 0 0 0 0 0 0 48
Completed 0 0 0 0 0 0 35
Not Completed 0 0 0 0 0 0 13
Reason Not Completed
Death             0             0             0             0             0             0             3
Adverse Event             0             0             0             0             0             0             1
Lack of Efficacy             0             0             0             0             0             0             3
Lost to Follow-up             0             0             0             0             0             0             1
Withdrawal by Subject             0             0             0             0             0             0             3
Poor or non-compliance             0             0             0             0             0             0             1
not specified             0             0             0             0             0             0             1
Arm/Group Title Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg) Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg) Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg) Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg) Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg) Placebo Total
Hide Arm/Group Description Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept). Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept). Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants were rolled over to a variable dose of abatacept SC administered weekly following an IV loading dose of abatacept on Day 85. Total of all reporting groups
Overall Number of Baseline Participants 7 4 29 6 5 17 68
Hide Baseline Analysis Population Description
Baseline includes all participants enrolled and treated. Baseline parameters are presented for each arm but the total value for baseline mean age and standard deviation (SD) includes all participants in LTE. Data are presented by treatment the participant actually received, not to what they were randomized to receive.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 4 participants 29 participants 6 participants 5 participants 17 participants 68 participants
72  (5) 64  (10) 59  (12) 51  (9) 55  (9) 59  (11) 60  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 4 participants 29 participants 6 participants 5 participants 17 participants 68 participants
Female
7
 100.0%
3
  75.0%
26
  89.7%
5
  83.3%
4
  80.0%
12
  70.6%
57
  83.8%
Male
0
   0.0%
1
  25.0%
3
  10.3%
1
  16.7%
1
  20.0%
5
  29.4%
11
  16.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 4 participants 29 participants 6 participants 5 participants 17 participants 68 participants
7 4 29 6 5 17 68
1.Primary Outcome
Title Short Term Period: Steady-state Trough Serum Concentration (Cmin) of Abatacept Following Weekly Subcutaneous Dosing in Participants With Active Rheumatoid Arthritis Receiving Disease Modifying Anti-rheumatic Drugs (DMARDS)
Hide Description Participants received abatacept while also receiving DMARDS over a short term (ST) 12 Week period. To eliminate contribution from the IV loading dose of abatacept during the short term study period, Cmin values were selected from Days 71 to 85, when contribution from IV was negligible. Minimum trough serum concentration of abatacept (Cmin) was measured in micrograms/milliliter (µg/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Time Frame Days 71 to 85
Hide Outcome Measure Data
Hide Analysis Population Description
50 of the 51 abatacept-treated subjects were included. One subject who discontinued after receiving only Day 1 dosing was not included in this analysis.
Arm/Group Title Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg) Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg) Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg) Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg) Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
Hide Arm/Group Description:
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Overall Number of Participants Analyzed 7 4 29 5 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
Day 71
22.64
(20.13%)
28.03
(42.13%)
24.05
(40.65%)
16.22
(24.39%)
26.52
(56.53%)
Day 78
21.66
(19.99%)
34.17
(29.49%)
24.41
(52.35%)
11.57
(32.25%)
29.21
(52.96%)
Day 85
23.62
(31.63%)
36.73
(31.64%)
24.93
(38.42%)
13.01
(41.35%)
27.53
(58.87%)
2.Primary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Reported During the Variable Dosing Phase of the Long Term Period (LTE)
Hide Description AEs during variable dose phase of LTE + 56 days post last dose in the variable dose phase or start of the fixed dose phase, which ever came first; includes deaths reported during the variable dose phase including those that occurred greater than 56 days after last dose. Medical Dictionary for Regulatory Activities (MedDRA) version: 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (included hospitalizations for elective surgical procedures). Treatment-related=having certain, probable, possible, or missing relationship to study drug. Data presented by treatment the participant was randomized to and not what they actually received.
Time Frame Day 85 to 56 days post last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants included those that rolled over into the LTE, receiving variable SC dosing of abatacept in the Variable Dose Period.
Arm/Group Title 75 mg SC Abatacept (Body Weight < 60 kg) 125 mg SC Abatacept (Body Weight <60 to >100 kg) 200 mg SC Abatacept (Body Weight > 100 kg)
Hide Arm/Group Description:
Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly), or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (1000 mg IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
Overall Number of Participants Analyzed 11 42 10
Measure Type: Number
Unit of Measure: participants
Deaths 0 1 0
Participants with SAEs 2 13 4
Participants with drug related SAEs 1 2 1
Participants discontinued due to SAEs 0 1 1
Participants with AEs 9 38 9
Participants with drug related AEs 2 20 3
Participants discontinued due to AEs 1 2 1
3.Primary Outcome
Title Number of Participants With Pre-specified AEs of Special Interest in the Variable Dosing Phase of Long Term Extension (LTE)
Hide Description LTE period with variable abatacept dosing starting on Day 85 and continuing until Day 533 when LTE fixed dosing started. AEs of special interest: infection and/or infestation; neoplasms (malignant); pre-specified autoimmune disorder; infusional AEs (peri-infusional: pre-specified AEs occurring during first 24 hours (hrs) after start of the IV loading dose; acute infusional: pre-specified AEs occurring during the first hour after the start of the IV loading dose; systemic injection site reactions (SIR): pre-specified AEs for SIR; local injection site reaction: pre-specified AEs for local site reaction. Data are presented by treatment the participant was randomized to and not what they actually received.
Time Frame Day 85 to Day 533
Hide Outcome Measure Data
Hide Analysis Population Description
All 63 participants who completed the ST period enrolled into the LTE variable dosing period and were analyzed.
Arm/Group Title 75 mg SC Abatacept 125 mg SC Abatacept 200 mg SC Abatacept
Hide Arm/Group Description:
variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period); body weight <60kg. At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Body weight <60 to >100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period); body weight >100kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
Overall Number of Participants Analyzed 11 42 10
Measure Type: Number
Unit of Measure: participants
Number with Serious Infection/Infestation 1 1 2
Number with Malignant Neoplasms 1 5 1
Number with Autoimmune Disorder 0 1 0
Number with Acute Infusional Event 0 0 0
Number with Serious Systemic injection Reaction 0 0 0
Number with Local Injection Site Reaction 0 4 0
4.Primary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Discontinuations Due to Adverse Events Summarized Over the Entire Long Term Extension (LTE) Period (Both Variable and Fixed Dosing)
Hide Description On Day 85 participants rolled over into the LTE with variable dose phase first and at Day 533, a fixed dose phase of 125 mg abatacept SC weekly, irrespective of body weight. This summary includes AEs reported during entire LTE treatment plus 56 days post last dose; includes all deaths reported during the LTE including those that occurred greater than 56 days after last dose. MedDRA version: 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (also included hospitalizations for elective surgical procedures). Treatment-related=having certain, probable, possible, or missing relationship to study drug.
Time Frame Day 533 to 56 Days Post last dose
Hide Outcome Measure Data
Hide Analysis Population Description
total number of participants in the Long Term Extension Period.
Arm/Group Title SC Abatacept
Hide Arm/Group Description:
Overall summary of all participants in the LTE. LTE Period consisted of a variable dose (75 mg, 125 mg, 200 mg abatacept) phase first and at Day 533, a fixed dose phase of 125 mg abatacept SC weekly, irrespective of body weight.
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: participants
Deaths 6
Participants with SAEs 35
Participants with Drug Related SAEs 7
Participants Discontinued due to SAEs 3
Participants with AEs 61
Participants with Drug Related AEs 34
Participants Discontinued due to AEs 5
5.Secondary Outcome
Title Short Term Period: Peak Serum Concentration (Cmax) of Abatacept at Steady State in Participants With Rheumatoid Arthritis Receiving DMARDS
Hide Description Peak serum concentration (Cmax) of abatacept after weekly SC administration was determined between the SC dosing interval from Day 71 to 78. Abatacept in human serum was measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantification (LLOQ) was 0.001, Upper limit of quantification (ULOQ) was 0.030. Cmax measured in micrograms per milliliter(µg/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Time Frame Day 71 to Day 78
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included those participants treated with abatacept and having PK data available
Arm/Group Title Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg) Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg) Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg) Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg) Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
Hide Arm/Group Description:
Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
Overall Number of Participants Analyzed 7 4 26 5 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
26.3
(29.5%)
34.9
(46.6%)
31.9
(42.8%)
14.7
(44.3%)
41.7
(41.2%)
6.Secondary Outcome
Title Short Term Period: Area Under the Curve (AUC) in Time Interval of 7 Days [AUC(TAU)] of Abatacept in Participants With Rheumatoid Arthritis Receiving DMARDS
Hide Description The steady-state pharmacokinetic parameter AUC(TAU) of abatacept after weekly SC administration was determined between the SC dosing interval from Day 71 to 78 (TAU=7 days). Abatacept in human serum was measured by enzyme-linked immunosorbent assay (ELISA). Lower limit of quantification (LLOQ) was 0.001; Upper limit of quantification (ULOQ) was 0.030. AUC(TAU) measured in in micrograms*hours per milliliter (µg*h/mL). Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Time Frame Day 71 to Day 78
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included those participants treated with abatacept and having PK data available.
Arm/Group Title Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg) Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg) Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg) Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg) Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)
Hide Arm/Group Description:
Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
Overall Number of Participants Analyzed 7 3 24 4 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg*h/mL
4066
(22.2%)
6699
(20.7%)
4607
(38.6%)
2555
(30.1%)
5849
(40.5%)
7.Secondary Outcome
Title Short Term Period: Summary of Adverse Events (AEs), Serious AEs, Deaths, and Discontinuations Due to AEs During 12 Weeks of Treatment With Either Abatacept or Placebo
Hide Description Number of Participants with Adverse events (AEs), Serious AEs, discontinuations due to AEs, or Deaths occurring while participant was on treatment from Day 1 (treatment) to Day 85 or early termination from the study. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization (also included hospitalizations for elective surgical procedures). Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Time Frame Day 1 to Day 85 (or early termination)
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[Not Specified]
Arm/Group Title Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg) Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg) Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg) Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg) Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg) Placebo (by Body Weight Category)
Hide Arm/Group Description:
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
Overall Number of Participants Analyzed 7 4 29 6 5 17
Measure Type: Number
Unit of Measure: participants
Deaths 0 0 0 0 0 0
Participants with SAEs 0 1 1 0 1 0
Participants with AEs 5 3 21 6 5 11
Discontinued due to AEs 0 1 0 1 0 0
8.Secondary Outcome
Title Short Term Period: Number of Participants With Pre-specified Adverse Events (AEs) of Special Interest After Administration of Abatacept or Placebo Over 12 Weeks
Hide Description AEs of special interest: infection and/or infestation; neoplasms (benign, malignant, unspecified; autoimmune disorder; infusional AEs (peri-infusional: AEs occurring during first 24 hours (hrs) after start of the IV loading dose; acute infusional: AEs occurring during the first hour after the start of the IV loading dose; injection site AEs: AEs occurring at the site of the SC injection. Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Time Frame Day 1 to Day 85 (or early termination)
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All subjects treated were analyzed for safety.
Arm/Group Title Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg) Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg) Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg) Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg) Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg) Placebo (by Body Weight Category)
Hide Arm/Group Description:
Subjects randomized to abatacept in group 1 received an IV loading dose of abatacept on Day 1 of 500 mg followed by abatacept 75 mg SC (once weekly for 12 weeks).
Subjects randomized to abatacept in group 2 received an IV loading dose of abatacept on Day 1 of 500 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
Subjects randomized to abatacept in group 3 received an IV loading dose of abatacept on Day 1 of 750 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
Subjects randomized to abatacept in group 4 received an IV loading dose of abatacept on Day 1 of 1000 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
Subjects randomized to abatacept in group 5 received an IV loading dose of abatacept on Day 1 of 1000 mg followed by abatacept 200 mg SC (once weekly for 12 weeks).
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
Overall Number of Participants Analyzed 7 4 29 6 5 17
Measure Type: Number
Unit of Measure: participants
Number with Infection/Infestation events 3 1 9 3 1 4
Number with malignant neoplasm events 0 0 0 0 0 0
Number with autoimmune disorder events 0 0 0 0 0 0
Number with acute infusional events 0 0 2 1 0 0
Number with peri-infusional events 0 0 4 3 0 0
General disorders and injection site events 0 1 11 3 2 1
9.Secondary Outcome
Title Short Term Period: Mean Percent Change From Baseline on Day 85 in Participants Positive for Serum Rheumatoid Factor During Abatacept or Placebo Administration
Hide Description Serum samples were obtained on Days 1, 8, 15, 29, 57 and day of discharge (Day 85 or earlier) for determination of presence of rheumatoid factor (RF). Baseline was defined as Day 1 to calculate percent change. Lower limit of quantitation (LLQ) was 5 Units/milliliter (U/mL). Values below LLQ were set to 2.5 U/mL. Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Time Frame Day 1 to Day 85 (or early termination)
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Analysis set included all available data from participants who received abatacept or placebo. For RF analysis in Group 1 Day 1/Day 85 number of participants = 7/7; Group 2 = 3/3; Group 3 = 29/29; Group 4 = 6/6; Group 5 = 5/5; Placebo = 17/15 participants.
Arm/Group Title Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg) Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg) Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg) Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg) Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg) Placebo (by Body Weight Category)
Hide Arm/Group Description:
Short term (ST) 12 week period: Abatacept as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks).
Short term (ST) 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
Overall Number of Participants Analyzed 7 3 29 6 5 15
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
-1.50  (43.50) -8.89  (3.14) -17.69  (26.61) -16.29  (16.24) -19.32  (15.21) 43.72  (154.47)
10.Secondary Outcome
Title Short Term Period: Number of Participants With Laboratory Abnormalities in Hematology at Baseline (Day 1) to End of Period (Day 85)
Hide Description Blood samples were obtained: At screening, within 24 hours prior to study drug administration on Day 1, on Days 15, 29, 57 and at study discharge. Baseline (BL) defined as Day 1 prior to treatment. Common toxicity criteria (CTC), Version 3 used to assess parameters. lower limit of normal (LLN). ANC=absolute neutrophil count. White blood cells Grade (Gr) 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Lymphocytes Gr 1: <LLN to 3.0, Gr 2: 2.0 < 3.0, Gr 3: 1.0 to < 2.0, Gr 4; < 1.0. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Hematocrit (%): <0.75*pre-treatment. Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Time Frame Day 1 to Day 85 (or early termination)
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All participants treated with either abatacept or placebo. Participant counted once in total for each arm but participant could have multiple AEs of different grade. Grade category is number of participants with that Grade of AE (Grades 1, 2, 3, 4)
Arm/Group Title Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg) Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg) Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg) Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg) Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg) Placebo (by Body Weight Category)
Hide Arm/Group Description:
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
Overall Number of Participants Analyzed 7 4 29 6 5 17
Measure Type: Number
Unit of Measure: participants
Baseline (Day 1 prior to treatment) Total 4 3 15 1 2 9
Grade 1 baseline 4 3 13 1 2 8
Grade 2 baseline 0 1 2 0 0 3
Grade 3 baseline 0 0 1 0 0 0
Grade 4 baseline 0 0 0 0 0 0
Day 1 after treatment to Day 85 Total 4 4 20 1 4 13
Grade 1 on treatment 4 4 17 1 3 11
Grade 2 on treatment 0 1 6 0 1 3
Grade 3 on treatment 0 0 0 0 0 1
Grade 4 on treatment 0 0 0 0 0 0
11.Secondary Outcome
Title Short Term Period: Number of Participants With Laboratory Abnormalities in Serum Chemistry at Baseline and on Treatment up to Day 85
Hide Description Screening, BL, Days 15, 29, 57, 85 or discharge. Upper limit of normal (ULN). CTC grade (Gr): Alanine transaminase Gr 1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Aspartate aminotransferase Gr 1: >ULN to 2.5*ULN; Gr 2:>2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. G-Glutamyl Transferase (U/L) Gr 1:>ULN to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Alkaline phosphatase (U/L) Gr 1:>ULN to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4: >20.0*ULN; creatinine (mg/dL) Gr 1: >ULN to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 6.0*ULN; Gr 4: >10.0*ULN. Albumin (g/dL) Gr 1:<LLN to 3.0; Gr 2:<3.0 to 2.0; Gr 3: <2.0. Uric Acid (mg/dL)Gr 1: >1.0 x ULN to 10.0; Gr 4: >10.0. Sodium (mEq/L) Gr 1: >ULN to 150; Gr 2: >150 to 155; Gr 3: >155 to 160; Gr 4: > 160. Potassium (mEq/L) Gr 1: >ULN to 5.5; Gr 2: >5.5 to 6.0; Gr 3: >6.0 to 7.0; Gr 4: >7.0. Data presented by treatment participant actually received.
Time Frame Day 1 to Day 85 (or early termination)
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All participants treated with abatacept or placebo in the short term period. Participant is counted once in total but could have multiple AEs of different grade. Grade category is number of participants with that Grade of AE (Grades 1, 2, 3, 4)
Arm/Group Title Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg) Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg) Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg) Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg) Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg) Placebo (by Body Weight Category)
Hide Arm/Group Description:
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
Overall Number of Participants Analyzed 7 4 29 6 5 17
Measure Type: Number
Unit of Measure: participants
Baseline (Day 1 prior to treatment) Total 2 2 6 1 4 7
Grade 1 baseline 2 2 5 1 4 7
Grade 2 baseline 0 0 1 0 0 2
Grade 3 baseline 0 0 0 0 0 0
Grade 4 baseline 0 0 0 0 0 0
Day 1 (after treatment) to Day 85 Total 5 4 18 3 4 15
Grade 1 on treatment 5 0 18 3 3 15
Grade 2 on treatment 1 0 4 0 0 4
Grade 3 on treatment 0 0 0 0 1 1
Grade 4 on treatment 0 0 0 0 1 0
12.Secondary Outcome
Title Short Term Period: Mean Change From Baseline at Day 85 in Blood Pressure After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS
Hide Description Blood pressure (systolic and diastolic) was recorded while the participant was seated during the screening visit, at baseline on Day 1 (prior to administration of IV infusion), prior to administration of all SC injections, and at study discharge (Day 85 or 7 days after the last dose for subjects who terminated early). In addition, blood pressure was recorded at 30 and 60 minutes after the start of the IV infusion on Day 1, and 30 and 60 minutes after all SC injections. Blood pressure was measured in millimeters of mercury (mm Hg). Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Time Frame Day 1 to Day 85 (or early termination)
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All participants who were treated with abatacept or placebo and had vital signs taken were analyzed throughout the 12 weeks. At Day 85 N = 6, 3, 28,6, 5, 17 in groups 1, 2, 3, 4, 5, Placebo, respectively
Arm/Group Title Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg) Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg) Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg) Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg) Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg) Placebo (by Body Weight Category)
Hide Arm/Group Description:
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
Overall Number of Participants Analyzed 7 4 29 6 5 17
Mean (Standard Deviation)
Unit of Measure: mm Hg
Change from baseline in Diastolic blood pressure -5.2  (10.0) 0.0  (13.1) 0.7  (7.5) 3.5  (11.2) -5.4  (9.6) 1.8  (8.3)
Change from baseline in Systolic blood pressure -4.0  (12.1) -6.3  (6.8) 0.3  (17.8) -0.8  (8.2) -4.2  (10.5) 0.2  (12.1)
13.Secondary Outcome
Title Short Term Period: Mean Change From Baseline at Day 85 in Pulse Rate After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS
Hide Description Pulse rate was taken while participant was seated. Pulse rate was recorded during the screening visit, at baseline on Day 1 (prior to administration of IV infusion), prior to administration of all SC injections, and at study discharge (Day 85 or 7 days after the last dose for subjects who terminated early). In addition, vital signs were recorded at 30 and 60 minutes after the start of the IV infusion on Day 1, and 30 and 60 minutes after all SC injections. Pulse rate measured in beats/min (bpm). Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Time Frame Day 1 to Day 85 (or early termination)
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All participants who were treated with abatacept or placebo and had vital signs taken were analyzed throughout the 12 weeks. At Day 85 N = 6, 3, 28, 6, 5, 17 in groups 1, 2, 3, 4, 5, Placebo, respectively
Arm/Group Title Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg) Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg) Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg) Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg) Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg) Placebo (by Body Weight Category)
Hide Arm/Group Description:
Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
Overall Number of Participants Analyzed 7 4 29 6 5 17
Mean (Standard Deviation)
Unit of Measure: bpm
-2.9  (10.0) 0.3  (11.1) -0.6  (9.5) 3.5  (10.5) -11.4  (9.0) -1.0  (7.1)
14.Secondary Outcome
Title Short Term Period: Mean Change From Screening to Day 85 in Electrocardiogram (QT, PR Intervals, QRS Width) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS
Hide Description A 12-lead electrocardiogram (ECG) was recorded at screening and at discharge from the study (Day 85 or 7 days after the last dose of study drug for those subjects who terminated early). If there was no history of known cardiac events, an ECG was performed within 6 months of study entry, and documentation was on file, then the screening ECG was not repeated at screening. QT interval, PR interval and QRW Width were reported in milliseconds (msec). If no ECG issues were found in the 12 weeks of the Short Term Period, ECG was not repeated during LTE. Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Time Frame Screening to Day 85 (or early termination)
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A total of 68 participants were treated with abatacept or placebo: 66 had results at screening and 52 had results at Discharge (Day 85) for QT interval and QRS Width; 65 and 51 participants had PR interval results at Screening and Discharge (Day 85), respectively.
Arm/Group Title All Treated Participants
Hide Arm/Group Description:
ECG change from screening after treatment were summarized for all participants treated with either abatacept or placebo in the Short Term Period.
Overall Number of Participants Analyzed 66
Mean (Standard Deviation)
Unit of Measure: msec
Change from Screening in QT interval (N=52) -1.47  (24.72)
Change from Screening in PR interval (N=51) 5.28  (21.10)
Change from Screening in QRS Width (N=52) 0.22  (11.03)
15.Secondary Outcome
Title Short Term Period: Mean Change From Screening at Day 85 in ECG (Heart Rate) After SC Administration of Abatacept or Placebo in Participants With Rheumatoid Arthritis Receiving DMARDS
Hide Description A 12-lead electrocardiogram (ECG) was recorded at screening and at discharge from the study (Day 85 or 7 days after the last dose of study drug for those subjects who terminated early). If there was no history of known cardiac events, an ECG was performed within 6 months of study entry, and documentation was on file, then the screening ECG was not repeated at screening. Heart Rate was reported in beats per minute (bpm). In no ECG issues were found in the 12 weeks of the Short Term Period, ECG was not repeated during LTE. Data are presented by treatment the participant actually received, not by what they were randomized to receive.
Time Frame Screening to Day 85 (or early termination)
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Hide Analysis Population Description
A total of 68 participants were treated with abatacept or placebo: 65 had results at screening and 53 had results at Discharge (Day 85) for Heart Rate.
Arm/Group Title All Treated Participants
Hide Arm/Group Description:
ECG Heart Rate change from screening after treatment were summarized for all participants treated with either abatacept or placebo in the Short Term Period
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: bpm
0.51  (8.43)
16.Secondary Outcome
Title Overall Study ST and LTE Periods: Number of Participants With Anti-abatacept Antibodies and/or Anti-cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibodies
Hide Description Assessment of positive antibody response based upon analysis using a validated enzyme-linked immunosorbent assay (ELISA) with a cut-off value. CTLA4 is a protein receptor that downregulates the immune system. Short Term (ST) period was initial 12 Weeks of the study. Overall LTE includes both the variable and fixed abatacept dosing periods and was from the end of the ST period (Day 85) up to 168 days post last dose (treatment in LTE ranged from 4.4 to 74.2 months. Data in the ST period are summarized by the treatment the participants actually received, while the LT period data are summarized by treatment the participant was randomized to receive.
Time Frame ST: Day 1 to Day 85; LTE: Day 85 to 168 days post last dose
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In the ST period, only subjects treated with abatacept (51) were evaluated for antibodies. In LTE, 61 participants were analyzed for anti-abatacept antibodies, and 62 participants were analyzed for CTLA4-T antibodies. Participants were analyzed during treatment and post-treatment (28, 56, 85, and 168 days post-treatment).
Arm/Group Title Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg) Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg) Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg) Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg) Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg) LTE (Variable and Fixed Dosing Abatacept)
Hide Arm/Group Description:
Short term (ST) 12 week period: Abatacept as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks)
Short term (ST) 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
Short term (ST) 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
Long term extension (LTE) consisted of 2 periods: variable dosing of abatacept combined with DMARDS and fixed dosing abatacept combined with DMARDS. Participants were weighed prior to starting LTE (variable dosing) and dosing was assigned per body weight category. Variable dosing period required an IV loading dose prior to starting SC dosing (if participant had been randomized to placebo in the short term period). Variable dosing: 500 mg IV/75 mg SC and 500 mg IV/125 mg SC in participants less than (<)60 kg body weight; 750 mg IV/125 mg SC in participants between 60 and 100 kg body weight; 1000 mg IV/125 mg SC and 1000 mg IV/200 mg SC in participants greater than (>) 100 kg body weight. Participants were rolled over into a fixed SC dose of 125 mg per week in the fixed dosing period prior to their Year 2 anniversary visit for the study (as early as Day 533).
Overall Number of Participants Analyzed 7 4 29 6 5 62
Measure Type: Number
Unit of Measure: participants
Number with anti-abatacept antibodies 0 0 0 1 0 11
Number with anti-CTLA4 antibodies 0 0 0 0 0 1
Time Frame Day 1 of short term study up to 71 months in the long term study.
Adverse Event Reporting Description AEs and SAEs are summarized by the treatment arm to which the participants were randomized.
 
Arm/Group Title Abatacept 1000mg IV/125mg SC Abatacept 1000mg IV/200mg SC Abatacept 500mg IV/125mg SC Abatacept 500mg IV/75mg SC Abatacept 750mg IV/125mg SC Abatacept (LT) 125 mg SC Placebo (ST)
Hide Arm/Group Description Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period. Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period. Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period. Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period. Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period. Participants who completed the long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (as described in Groups 1 - 5) were rolled over into the LTE with fixed dose: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly. Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
All-Cause Mortality
Abatacept 1000mg IV/125mg SC Abatacept 1000mg IV/200mg SC Abatacept 500mg IV/125mg SC Abatacept 500mg IV/75mg SC Abatacept 750mg IV/125mg SC Abatacept (LT) 125 mg SC Placebo (ST)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abatacept 1000mg IV/125mg SC Abatacept 1000mg IV/200mg SC Abatacept 500mg IV/125mg SC Abatacept 500mg IV/75mg SC Abatacept 750mg IV/125mg SC Abatacept (LT) 125 mg SC Placebo (ST)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   0/5 (0.00%)   1/5 (20.00%)   0/6 (0.00%)   1/28 (3.57%)   35/63 (55.56%)   0/18 (0.00%) 
Blood and lymphatic system disorders               
Anaemia  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  2/63 (3.17%)  0/18 (0.00%) 
Cardiac disorders               
Atrial flutter  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Cardiac failure congestive  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  2/63 (3.17%)  0/18 (0.00%) 
Atrial fibrillation  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  2/63 (3.17%)  0/18 (0.00%) 
Myocardial infarction  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  2/63 (3.17%)  0/18 (0.00%) 
Sick sinus syndrome  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Diastolic dysfunction  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  0/18 (0.00%) 
Ear and labyrinth disorders               
Vertigo  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Gastrointestinal disorders               
Gastritis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Abdominal pain  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Erosive oesophagitis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Gastrointestinal haemorrhage  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Peptic ulcer haemorrhage  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
General disorders               
Chest discomfort  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  0/18 (0.00%) 
Adverse drug reaction  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Death  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Injection site reaction  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Impaired healing  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Chest pain  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Infections and infestations               
Lobar pneumonia  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Pneumonia  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Wound infection  1  0/6 (0.00%)  0/5 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  0/18 (0.00%) 
Meningitis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
H1N1 influenza  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Staphylococcal infection  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Urinary tract infection  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  3/63 (4.76%)  0/18 (0.00%) 
Gastroenteritis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Injury, poisoning and procedural complications               
Overdose  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  0/63 (0.00%)  0/18 (0.00%) 
Hip fracture  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Spinal fracture  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Metabolism and nutrition disorders               
Diabetes mellitus inadequate control  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Rotator cuff syndrome  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Spinal disorder  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Lumbar spinal stenosis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Joint contracture  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Rheumatoid arthritis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Osteoarthritis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  5/63 (7.94%)  0/18 (0.00%) 
Intervertebral disc disorder  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Basal cell carcinoma  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  7/63 (11.11%)  0/18 (0.00%) 
Colon cancer  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Lip neoplasm malignant stage unspecified  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Malignant melanoma  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  2/63 (3.17%)  0/18 (0.00%) 
Squamous cell carcinoma of skin  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  2/63 (3.17%)  0/18 (0.00%) 
Squamous cell carcinoma  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Nervous system disorders               
Presyncope  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Transient ischaemic attack  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Psychiatric disorders               
Mental status changes  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Renal and urinary disorders               
Renal failure acute  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Emphysema  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Asthma  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  2/63 (3.17%)  0/18 (0.00%) 
Dyspnoea  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Sleep apnoea syndrome  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  0/18 (0.00%) 
Chronic obstructive pulmonary disease  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Vascular disorders               
Iliac artery occlusion  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abatacept 1000mg IV/125mg SC Abatacept 1000mg IV/200mg SC Abatacept 500mg IV/125mg SC Abatacept 500mg IV/75mg SC Abatacept 750mg IV/125mg SC Abatacept (LT) 125 mg SC Placebo (ST)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   5/5 (100.00%)   2/5 (40.00%)   5/6 (83.33%)   18/28 (64.29%)   58/63 (92.06%)   12/18 (66.67%) 
Blood and lymphatic system disorders               
Anaemia  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  8/63 (12.70%)  0/18 (0.00%) 
Lymphadenopathy  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  1/18 (5.56%) 
Ear and labyrinth disorders               
Ear pain  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Eye disorders               
Cataract  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  8/63 (12.70%)  0/18 (0.00%) 
Vision blurred  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  1/63 (1.59%)  0/18 (0.00%) 
Glaucoma  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/28 (0.00%)  2/63 (3.17%)  0/18 (0.00%) 
Gastrointestinal disorders               
Gastritis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  5/63 (7.94%)  0/18 (0.00%) 
Gastrooesophageal reflux disease  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  9/63 (14.29%)  0/18 (0.00%) 
Vomiting  1  1/6 (16.67%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  2/28 (7.14%)  4/63 (6.35%)  0/18 (0.00%) 
Food poisoning  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/28 (0.00%)  0/63 (0.00%)  0/18 (0.00%) 
Nausea  1  1/6 (16.67%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  2/28 (7.14%)  10/63 (15.87%)  1/18 (5.56%) 
Diarrhoea  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  2/28 (7.14%)  8/63 (12.70%)  2/18 (11.11%) 
Abdominal discomfort  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  3/63 (4.76%)  1/18 (5.56%) 
Irritable bowel syndrome  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  0/18 (0.00%) 
General disorders               
Chest discomfort  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Chills  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  2/28 (7.14%)  0/63 (0.00%)  0/18 (0.00%) 
Injection site reaction  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  3/28 (10.71%)  1/63 (1.59%)  0/18 (0.00%) 
Injection site haematoma  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Injection site warmth  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  2/28 (7.14%)  0/63 (0.00%)  0/18 (0.00%) 
Oedema peripheral  1  2/6 (33.33%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  12/63 (19.05%)  0/18 (0.00%) 
Asthenia  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  3/63 (4.76%)  0/18 (0.00%) 
Fatigue  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  7/63 (11.11%)  0/18 (0.00%) 
Injection site erythema  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  0/63 (0.00%)  1/18 (5.56%) 
Injection site pain  1  0/6 (0.00%)  0/5 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  3/28 (10.71%)  1/63 (1.59%)  1/18 (5.56%) 
Injection site swelling  1  1/6 (16.67%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  0/63 (0.00%)  0/18 (0.00%) 
Pyrexia  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  2/28 (7.14%)  5/63 (7.94%)  0/18 (0.00%) 
Infections and infestations               
Bronchitis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/28 (0.00%)  13/63 (20.63%)  1/18 (5.56%) 
Gastroenteritis viral  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  2/28 (7.14%)  3/63 (4.76%)  0/18 (0.00%) 
Sinusitis  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  14/63 (22.22%)  0/18 (0.00%) 
Pneumonia  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Tooth abscess  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  1/28 (3.57%)  5/63 (7.94%)  1/18 (5.56%) 
Viral upper respiratory tract infection  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  1/18 (5.56%) 
Influenza  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  5/63 (7.94%)  0/18 (0.00%) 
Otitis externa  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  0/18 (0.00%) 
Upper respiratory tract infection  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  3/28 (10.71%)  22/63 (34.92%)  2/18 (11.11%) 
Urinary tract infection  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  4/28 (14.29%)  13/63 (20.63%)  0/18 (0.00%) 
Viral infection  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Nasopharyngitis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  8/63 (12.70%)  0/18 (0.00%) 
Injury, poisoning and procedural complications               
Rib fracture  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  1/28 (3.57%)  3/63 (4.76%)  0/18 (0.00%) 
Arthropod bite  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Ligament sprain  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  5/63 (7.94%)  0/18 (0.00%) 
Procedural pain  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Contusion  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Foot fracture  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  1/63 (1.59%)  0/18 (0.00%) 
Fall  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  2/6 (33.33%)  0/28 (0.00%)  7/63 (11.11%)  0/18 (0.00%) 
Nail injury  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/28 (0.00%)  0/63 (0.00%)  0/18 (0.00%) 
Laceration  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  7/63 (11.11%)  1/18 (5.56%) 
Tendon rupture  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Investigations               
Intraocular pressure increased  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Transaminases increased  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Urine analysis abnormal  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/28 (0.00%)  2/63 (3.17%)  0/18 (0.00%) 
Hepatic enzyme increased  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  1/18 (5.56%) 
Weight decreased  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  1/18 (5.56%) 
Liver function test abnormal  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Metabolism and nutrition disorders               
Dehydration  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  1/18 (5.56%) 
Hypokalaemia  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  5/63 (7.94%)  0/18 (0.00%) 
Fluid retention  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Hypercholesterolaemia  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  4/63 (6.35%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders               
Pain in extremity  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  7/63 (11.11%)  0/18 (0.00%) 
Neck pain  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  4/63 (6.35%)  0/18 (0.00%) 
Back pain  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  3/28 (10.71%)  14/63 (22.22%)  3/18 (16.67%) 
Musculoskeletal pain  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  1/28 (3.57%)  7/63 (11.11%)  0/18 (0.00%) 
Osteopenia  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Osteoarthritis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Bursitis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Muscle spasms  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  3/63 (4.76%)  1/18 (5.56%) 
Nervous system disorders               
Dizziness  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  5/63 (7.94%)  3/18 (16.67%) 
Headache  1  3/6 (50.00%)  2/5 (40.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  8/63 (12.70%)  3/18 (16.67%) 
Neuropathy peripheral  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Sciatica  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  4/63 (6.35%)  0/18 (0.00%) 
Carpal tunnel syndrome  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  1/18 (5.56%) 
Sinus headache  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  0/18 (0.00%) 
Psychiatric disorders               
Anxiety  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  2/28 (7.14%)  2/63 (3.17%)  0/18 (0.00%) 
Depression  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  5/63 (7.94%)  0/18 (0.00%) 
Insomnia  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  2/63 (3.17%)  1/18 (5.56%) 
Renal and urinary disorders               
Pollakiuria  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Rhinitis allergic  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  1/18 (5.56%) 
Sinus congestion  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Cough  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/6 (16.67%)  2/28 (7.14%)  13/63 (20.63%)  0/18 (0.00%) 
Pulmonary hypertension  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  1/63 (1.59%)  0/18 (0.00%) 
Asthma  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  6/63 (9.52%)  0/18 (0.00%) 
Productive cough  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  6/63 (9.52%)  0/18 (0.00%) 
Dyspnoea  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  11/63 (17.46%)  0/18 (0.00%) 
Rhinorrhoea  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  1/6 (16.67%)  1/28 (3.57%)  1/63 (1.59%)  0/18 (0.00%) 
Respiratory tract congestion  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Oropharyngeal pain  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  2/63 (3.17%)  1/18 (5.56%) 
Pleural effusion  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders               
Pruritus  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  2/28 (7.14%)  3/63 (4.76%)  0/18 (0.00%) 
Rash  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  8/63 (12.70%)  1/18 (5.56%) 
Actinic keratosis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  5/63 (7.94%)  1/18 (5.56%) 
Dermatitis  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  4/63 (6.35%)  0/18 (0.00%) 
Scab  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  0/18 (0.00%) 
Urticaria  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  2/28 (7.14%)  1/63 (1.59%)  0/18 (0.00%) 
Vascular disorders               
Flushing  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  2/63 (3.17%)  1/18 (5.56%) 
Haemorrhage  1  0/6 (0.00%)  0/5 (0.00%)  1/5 (20.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  0/18 (0.00%) 
Hypotension  1  0/6 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  1/28 (3.57%)  1/63 (1.59%)  1/18 (5.56%) 
Hypertension  1  1/6 (16.67%)  0/5 (0.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  6/63 (9.52%)  0/18 (0.00%) 
Phlebitis superficial  1  0/6 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/6 (0.00%)  0/28 (0.00%)  0/63 (0.00%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Error resulted in 4 participants being treated with study drug they were not randomized to receive. ST data were summarized by study drug participants actually received while LT data were summarized by what participants were randomized to receive.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00254293     History of Changes
Other Study ID Numbers: IM101-063
First Submitted: November 15, 2005
First Posted: November 16, 2005
Results First Submitted: August 20, 2013
Results First Posted: April 8, 2014
Last Update Posted: April 8, 2014