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Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients

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ClinicalTrials.gov Identifier: NCT01351480
Recruitment Status : Completed
First Posted : May 11, 2011
Results First Posted : March 13, 2017
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Norman B. Gaylis, MD, Arthritis & Rheumatic Disease Specialties Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Biological: abatacept
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abatacept
Hide Arm/Group Description

open label use of abatacept for 12 months

abatacept: Abatacept administered SC weekly at 125 mg dose

Period Title: Overall Study
Started 34
Completed 26
Not Completed 8
Arm/Group Title Abatacept
Hide Arm/Group Description

open label use of abatacept for 12 months

abatacept: Abatacept administered SC weekly at 125 mg dose

Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
  82.4%
>=65 years
6
  17.6%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants
57
(32 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
30
  88.2%
Male
4
  11.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
1.Primary Outcome
Title Number of Participants With an Improvement in Bone Edema/Osteitis on Low-field MRI in Rheumatoid Arthritis Patients on Weekly SC Abatacept in Combination With Methotrexate Over a 12-month Period.
Hide Description bone edema/osteitis using low-field MRI analysis of 25 anatomical locations in the wrist and hand and scoring the volume of the original articular bone in 0.5 increments from 0-3, with each increment in the scale representing 33% of the volume of the peripheral 1 cm of original (eroded + residual) articular bone.
Time Frame MRIs at Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
osteitis on the MRIs from 27 patients at baseline and week 48
Arm/Group Title Abatacept
Hide Arm/Group Description:

open label use of abatacept for 12 months

abatacept: Abatacept administered SC weekly at 125 mg dose

Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
27
2.Secondary Outcome
Title Patients With an Improvement in DAS Score Were Considered Responders at Week 48
Hide Description Patient with a positive change in DAS score were considered responders . The DAS score is calculated using the number of tender and swollen joints based upon a 28 joint count, the ESR in mm/hr., and the physician global score
Time Frame The DAS 28 score will be performed at baseline and 48
Hide Outcome Measure Data
Hide Analysis Population Description
There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients
Arm/Group Title Abatacept
Hide Arm/Group Description:

open label use of abatacept for 12 months

abatacept: Abatacept administered SC weekly at 125 mg dose

Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
25
3.Secondary Outcome
Title To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24
Hide Description DAS 28> 5.1=high disease activity DAS28 <3.2=low disease activity DAS28 <2.6=remission Criteria used in formula are number of tender joints based upon 28 joints, number of swollen joints based on 28 joints, ESR in mm/hr and patient global health core based on 0-10 mm
Time Frame Patient DAS 28 scores will be measured at baseline and weeks 12, 24, 48 and disease activity will be recorded at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
the number of participants who reached remission, low disease activity, moderate disease activity and high disease activity will be determined as based upon the DAS scale
Arm/Group Title Abatacept
Hide Arm/Group Description:

open label use of abatacept for 12 months

abatacept: Abatacept administered SC weekly at 125 mg dose

Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
clinical remission at week 12 2
low disease activity at week 12 2
mod disease activity at week 12 12
high disease activity at week 12 11
clinical remission at week 24 1
low disease activity at week 24 2
moderate disease activity at week 24 14
high disease activity at week 24 8
clinical remission at week 48 4
low disease activity at week 48 6
moderate disease activity at week 48 8
high disease activity at week 48 7
4.Secondary Outcome
Title the Clinical Outcomes Measurements (American College of Rheumatology Activity Scoring, Health Assessment The Number of Patients With a Clinical Response at Week 24 and 48
Hide Description Patient with a positive change in DAS score were considered responders . The DAS score is calculated using the number of tender and swollen joints based upon a 28 joint count, the ESR in mm/hr., and the physician global score (1-10 cm). Total maximum score was at high disease activity at baseline.
Time Frame week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients
Arm/Group Title Abatacept
Hide Arm/Group Description:

open label use of abatacept for 12 months

abatacept: Abatacept administered SC weekly at 125 mg dose

Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
clinical response at 6 months 20
clinical response at 12 months 25
5.Secondary Outcome
Title Number of Patients With Adverse Events
Hide Description site will report the number of patients with adverse envents from Day 1 up to 52 weeks
Time Frame all adverse events will be captured from Day 1 up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients
Arm/Group Title Abatacept
Hide Arm/Group Description:

open label use of abatacept for 12 months

abatacept: Abatacept administered SC weekly at 125 mg dose

Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
0
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abatacept
Hide Arm/Group Description

open label use of abatacept for 12 months

abatacept: Abatacept administered SC weekly at 125 mg dose

All-Cause Mortality
Abatacept
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abatacept
Affected / at Risk (%)
Total   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Abatacept
Affected / at Risk (%)
Total   0/27 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Norman B Gaylis, MD
Organization: AARDS Research, Inc.
Phone: 305-652-6676
EMail: drnbg@rheum-care.com
Layout table for additonal information
Responsible Party: Norman B. Gaylis, MD, Arthritis & Rheumatic Disease Specialties Research
ClinicalTrials.gov Identifier: NCT01351480     History of Changes
Other Study ID Numbers: IM101-306
First Submitted: May 6, 2011
First Posted: May 11, 2011
Results First Submitted: October 1, 2015
Results First Posted: March 13, 2017
Last Update Posted: March 13, 2017