Phase IIIB Switching From Intravenous to Subcutaneous Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00663702

First received: April 18, 2008

Last updated: February 22, 2012

Last verified: February 2012

History of Changes

Results First Received: January 19, 2012

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Arthritis, Rheumatoid
Intervention:	Drug: Abatacept

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 3 locations and 32 sites worldwide: United States (20 sites), Canada (6 sites), and Mexico (6 sites).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 126 participants were enrolled, and 3 discontinued prior to study start due to failure to continue to meet study eligibility criteria.

Reporting Groups

	Description
Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Description

Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)

Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or Bristol-Myers Squibb [BMS] IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)

Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.

Participant Flow for 2 periods

Period 1: Days 1 to 85

	Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)	Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
STARTED	52	71
COMPLETED	49	71
NOT COMPLETED	3	0
Adverse Event	1	0
Withdrawal by Subject	1	0
Lost to Follow-up	1	0

Period 2: Cumulative Period (Day 1 to Month 20)

	Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)	Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)
STARTED	52 ^[1]	71 ^[1]
COMPLETED	43	69
NOT COMPLETED	9	2
Adverse Event	3	1
Participant Withdrew Consent	3	0
Lack of Efficacy	2	1
Lost to Follow-up	1	0

[1]	Because Cumulative Phase includes Days 1 to 85, this number includes all participants from Day 1.

Baseline Characteristics

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Reporting Groups

	Description
Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and failed therapy with antitumor necrosis factor (anti-TNF) in an earlier study (NCT00048581, or BMS IM101-029), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)	Participants with active rheumatoid arthritis, who previously received intravenous abatacept and showed an inadequate response to treatment with methotrexate in an earlier study (NCT00048568,or BMS IM101-102), received subcutaneous abatacept, 125 mg, once weekly for 3 months (to Day 85). Participants received the first dose of subcutaneous abatacept within 4 weeks of the last quarterly dosing visit of the preceding intravenous abatacept study.
Total	Total of all reporting groups

Baseline Measures

	Subcutaneous Abatacept, 125 mg (Prior Anti-TNF Failure)	Subcutaneous Abatacept, 125 mg (Prior Methotrexate Failure)	Total
Number of Participants [units: participants]	52	71	123
Age [units: Years] Mean ± Standard Deviation	56.5 ± 10.2	52.8 ± 13.8	54.3 ± 12.5
Gender [units: Participants]
Female	42	59	101
Male	10	12	22
Race/Ethnicity, Customized [units: Partcipants]
White	47	70	117
Black/African American	3	0	3
American Indian/Alaska Native	1	0	1
Asian	0	1	1
Other	1	0	1
Region of Enrollment [units: Participants]
North America	52	16	68
South America	0	55	55
Mean Baseline High Sensitivity C-Reactive Protein Level [units: μg/mL] Mean ± Standard Deviation	0.94 ± 0.65	0.92 ± 0.88	0.93 ± 0.79
Mean Baseline 28 Joint Disease Activity Score (DAS 28) ^[1] [units: Score on a scale] Mean ± Standard Deviation	3.55 ± 1.20	3.28 ± 1.29	3.39 ± 1.26
Mean Number of Tender Joints at Baseline [units: Joints] Mean ± Standard Deviation	9.1 ± 12.8	8.8 ± 12.4	8.9 ± 12.5
Mean Number of Swollen Joints at Baseline [units: Joints] Mean ± Standard Deviation	5.4 ± 6.4	4.3 ± 5.9	4.8 ± 6.1
Participant Weight at Baseline [units: Participants]
Less than 60 kilograms	9	14	23
60-100 kilograms	30	54	84
Greater than 100 kilograms	10	3	13
Missing	3	0	3

[1]	The DAS 28 is a 28-item joint disease activity score used to quantify disease expression and progression in rheumatoid arthritis. Severity is indicated with increasing item score on the scale with 0=no joints affected and 28=all joints affected.

Outcome Measures

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1. Primary:

Number of Participants With Adverse Events (AEs), Treatment-related AEs, Discontinuations Due to AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, and Death As Outcome Through Day 85 [ Time Frame: Days 1 through 85 ]

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2. Primary:

Number of Participants With AEs of Special Interest Through Day 85 [ Time Frame: Days 1 through 85 ]

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3. Primary:

Number of Participants With Hematology Laboratory Values Meeting the Criteria for Marked Abnormality Through Day 85 [ Time Frame: Days 1 through 85 ]

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4. Primary:

Number of Participants With Liver and Kidney Function Laboratory Values Meeting the Criteria for Marked Abnormality Through Day 85 [ Time Frame: Days 1 through 85 ]

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5. Primary:

Number of Participants With Electrolyte Laboratory Values Meeting the Criteria for Marked Abnormality Through Day 85 [ Time Frame: Days 1 through 85 ]

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6. Primary:

Number of Participants With Chemistry Laboratory Values Meeting the Criteria for Marked Abnormality Through Day 85 [ Time Frame: Days 1 through 85 ]

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7. Primary:

Participants With Urinalysis Values Meeting the Criteria for Marked Abnormality Through Day 85 [ Time Frame: Days 1 through 85 ]

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8. Primary:

Mean Sitting Systolic and Diastolic Blood Pressure (BP) Through Day 85 [ Time Frame: Before injection on Days 1, 29, 57, and 85 ]

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9. Primary:

Mean Heart Rate Through Day 85 [ Time Frame: Before injection on Days 1, 26, 57, and 85 ]

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10. Primary:

Mean Temperature Through Day 85 [ Time Frame: Before injection on Days 1, 29, 57, and 85 ]

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11. Secondary:

Mean Trough Serum Concentration (Cmin) of Abatacept Through Day 85 [ Time Frame: Days 29, 85, 57, and 85 ]

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12. Secondary:

Percentage of Participants With A Positive Anti-abatacept Response (Based on Enzyme-linked Immunosorbent Assay [ELISA]) Through Day 85 [ Time Frame: Days 1 through 85 ]

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13. Secondary:

Percentage of Participants With A Positive Anti-abatacept Response (Based on Electrochemiluminescence [ECL] Immunoassay) Through Day 85 [ Time Frame: Days 1 through 85 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: clinical.trials@bms.com

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00663702 History of Changes
Other Study ID Numbers:	IM101-185
Study First Received:	April 18, 2008
Results First Received:	January 19, 2012
Last Updated:	February 22, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Mexico: National Institute of Public Health, Health Secretariat

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