Trial Outcomes & Findings for Rheumatoid Arthritis Memory B Cells and Abatacept (NCT NCT03652961)
NCT ID: NCT03652961
Last Updated: 2024-07-03
Results Overview
Clinical Disease Activity Index (CDAI) is a composite index used to assess rheumatoid arthritis (RA) disease activity. The CDAI score is the sum of the Swollen 28-Joint Count (SJC28) + Tender 28-Joint Count (TJC) + Patient Global disease Activity (PGA, patient's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) + Evaluator's Global disease Activity (EGA, evaluator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity). The total score range is 2-76; higher scores (CDAI \> 22) indicate HIgh Disease Activity.
COMPLETED
PHASE4
25 participants
Day 1
2024-07-03
Participant Flow
Participant milestones
| Measure |
Abatacept Plus DMARD
Abatacept will be used concomitantly with standard of care disease-modifying anti-rheumatic drugs (DMARDs), other than tumor necrosis factor (TNF) antagonists or Janus kinase (JAK) inhibitors.
Intravenous (IV) Abatacept will be administered as a 30-minute IV infusion utilizing weight range-based dosing:
1. Less than 60 kg: 500 mg
2. 60 to 100 kg: 750 mg
3. More than 100 kg: 1000 mg
Following the initial IV Abatacept administration, an IV infusion will be given at Weeks 2 and 4 after the first infusion and every 4 weeks thereafter for a total of 7 Abatacept doses.
Abatacept will be discontinued after 6 months in all patients. Patients who have flared or failed to achieve low disease activity at 6 months will exit the trial except for one post-study visit for lab work at 9 months. In patients who have achieved low disease activity, Abatacept will be held for 6 months or until a flare results while DMARD use is continued.
Abatacept: Abatacept for reconstitution and dilution prior to intravenous (IV) administration. Each single-use vial of Abatacept for injection provides 250-mg Abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg) for administration.
DMARDs: Patients will receive methotrexate or remain on pre-existing conventional synthetic disease-modifying anti-rheumatic drug (DMARD) if already prescribed.
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|---|---|
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Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Abatacept Plus DMARD
Abatacept will be used concomitantly with standard of care disease-modifying anti-rheumatic drugs (DMARDs), other than tumor necrosis factor (TNF) antagonists or Janus kinase (JAK) inhibitors.
Intravenous (IV) Abatacept will be administered as a 30-minute IV infusion utilizing weight range-based dosing:
1. Less than 60 kg: 500 mg
2. 60 to 100 kg: 750 mg
3. More than 100 kg: 1000 mg
Following the initial IV Abatacept administration, an IV infusion will be given at Weeks 2 and 4 after the first infusion and every 4 weeks thereafter for a total of 7 Abatacept doses.
Abatacept will be discontinued after 6 months in all patients. Patients who have flared or failed to achieve low disease activity at 6 months will exit the trial except for one post-study visit for lab work at 9 months. In patients who have achieved low disease activity, Abatacept will be held for 6 months or until a flare results while DMARD use is continued.
Abatacept: Abatacept for reconstitution and dilution prior to intravenous (IV) administration. Each single-use vial of Abatacept for injection provides 250-mg Abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg) for administration.
DMARDs: Patients will receive methotrexate or remain on pre-existing conventional synthetic disease-modifying anti-rheumatic drug (DMARD) if already prescribed.
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|---|---|
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Overall Study
Lost to Follow-up
|
3
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Overall Study
Screen Failure
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1
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Baseline Characteristics
Rheumatoid Arthritis Memory B Cells and Abatacept
Baseline characteristics by cohort
| Measure |
Abatacept Plus DMARD
n=21 Participants
Abatacept will be used concomitantly with standard of care disease-modifying anti-rheumatic drugs (DMARDs), other than tumor necrosis factor (TNF) antagonists or Janus kinase (JAK) inhibitors.
Intravenous (IV) Abatacept will be administered as a 30-minute IV infusion utilizing weight range-based dosing:
1. Less than 60 kg: 500 mg
2. 60 to 100 kg: 750 mg
3. More than 100 kg: 1000 mg
Following the initial IV Abatacept administration, an IV infusion will be given at Weeks 2 and 4 after the first infusion and every 4 weeks thereafter for a total of 7 Abatacept doses.
Abatacept will be discontinued after 6 months in all patients. Patients who have flared or failed to achieve low disease activity at 6 months will exit the trial except for one post-study visit for lab work at 9 months. In patients who have achieved low disease activity, Abatacept will be held for 6 months or until a flare results while DMARD use is continued.
Abatacept: Abatacept for reconstitution and dilution prior to intravenous (IV) administration. Each single-use vial of Abatacept for injection provides 250-mg Abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg) for administration.
DMARDs: Patients will receive methotrexate or remain on pre-existing conventional synthetic disease-modifying anti-rheumatic drug (DMARD) if already prescribed.
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|---|---|
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Age, Continuous
|
56.7 years
n=39 Participants
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|
Sex: Female, Male
Female
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14 Participants
n=39 Participants
|
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Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
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Region of Enrollment
United States
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21 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Day 1Clinical Disease Activity Index (CDAI) is a composite index used to assess rheumatoid arthritis (RA) disease activity. The CDAI score is the sum of the Swollen 28-Joint Count (SJC28) + Tender 28-Joint Count (TJC) + Patient Global disease Activity (PGA, patient's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) + Evaluator's Global disease Activity (EGA, evaluator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity). The total score range is 2-76; higher scores (CDAI \> 22) indicate HIgh Disease Activity.
Outcome measures
| Measure |
Abatacept Plus DMARD
n=21 Participants
Abatacept will be used concomitantly with standard of care disease-modifying anti-rheumatic drugs (DMARDs), other than tumor necrosis factor (TNF) antagonists or Janus kinase (JAK) inhibitors.
Intravenous (IV) Abatacept will be administered as a 30-minute IV infusion utilizing weight range-based dosing:
1. Less than 60 kg: 500 mg
2. 60 to 100 kg: 750 mg
3. More than 100 kg: 1000 mg
Following the initial IV Abatacept administration, an IV infusion will be given at Weeks 2 and 4 after the first infusion and every 4 weeks thereafter for a total of 7 Abatacept doses.
Abatacept will be discontinued after 6 months in all patients. Patients who have flared or failed to achieve low disease activity at 6 months will exit the trial except for one post-study visit for lab work at 9 months. In patients who have achieved low disease activity, Abatacept will be held for 6 months or until a flare results while DMARD use is continued.
Abatacept: Abatacept for reconstitution and dilution prior to intravenous (IV) administration. Each single-use vial of Abatacept for injection provides 250-mg Abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg) for administration.
DMARDs: Patients will receive methotrexate or remain on pre-existing conventional synthetic disease-modifying anti-rheumatic drug (DMARD) if already prescribed.
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|---|---|
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CDAI Score
|
36.06 score on a scale
Standard Deviation 14.59
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PRIMARY outcome
Timeframe: Month 6Clinical Disease Activity Index (CDAI) is a composite index used to assess rheumatoid arthritis (RA) disease activity. The CDAI score is the sum of the Swollen 28-Joint Count (SJC28) + Tender 28-Joint Count (TJC) + Patient Global disease Activity (PGA, patient's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) + Evaluator's Global disease Activity (EGA, evaluator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity). The total score range is 2-76; higher scores (CDAI \> 22) indicate HIgh Disease Activity.
Outcome measures
| Measure |
Abatacept Plus DMARD
n=18 Participants
Abatacept will be used concomitantly with standard of care disease-modifying anti-rheumatic drugs (DMARDs), other than tumor necrosis factor (TNF) antagonists or Janus kinase (JAK) inhibitors.
Intravenous (IV) Abatacept will be administered as a 30-minute IV infusion utilizing weight range-based dosing:
1. Less than 60 kg: 500 mg
2. 60 to 100 kg: 750 mg
3. More than 100 kg: 1000 mg
Following the initial IV Abatacept administration, an IV infusion will be given at Weeks 2 and 4 after the first infusion and every 4 weeks thereafter for a total of 7 Abatacept doses.
Abatacept will be discontinued after 6 months in all patients. Patients who have flared or failed to achieve low disease activity at 6 months will exit the trial except for one post-study visit for lab work at 9 months. In patients who have achieved low disease activity, Abatacept will be held for 6 months or until a flare results while DMARD use is continued.
Abatacept: Abatacept for reconstitution and dilution prior to intravenous (IV) administration. Each single-use vial of Abatacept for injection provides 250-mg Abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg) for administration.
DMARDs: Patients will receive methotrexate or remain on pre-existing conventional synthetic disease-modifying anti-rheumatic drug (DMARD) if already prescribed.
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|---|---|
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CDAI Score
|
6.86 score on a scale
Standard Deviation 5.87
|
PRIMARY outcome
Timeframe: Month 3Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP) is a composite index used to assess rheumatoid arthritis (RA) disease activity. The DAS-28 CRP score is calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (scored on 11-point Likert scale from 0 \[no disease activity\] to 10 \[maximum disease activity\]), and high-sensitivity C-reactive protein levels (in mg/L). DAS28-CRP Scores range from 0 to 10; higher scores indicate more active disease.
Outcome measures
| Measure |
Abatacept Plus DMARD
n=21 Participants
Abatacept will be used concomitantly with standard of care disease-modifying anti-rheumatic drugs (DMARDs), other than tumor necrosis factor (TNF) antagonists or Janus kinase (JAK) inhibitors.
Intravenous (IV) Abatacept will be administered as a 30-minute IV infusion utilizing weight range-based dosing:
1. Less than 60 kg: 500 mg
2. 60 to 100 kg: 750 mg
3. More than 100 kg: 1000 mg
Following the initial IV Abatacept administration, an IV infusion will be given at Weeks 2 and 4 after the first infusion and every 4 weeks thereafter for a total of 7 Abatacept doses.
Abatacept will be discontinued after 6 months in all patients. Patients who have flared or failed to achieve low disease activity at 6 months will exit the trial except for one post-study visit for lab work at 9 months. In patients who have achieved low disease activity, Abatacept will be held for 6 months or until a flare results while DMARD use is continued.
Abatacept: Abatacept for reconstitution and dilution prior to intravenous (IV) administration. Each single-use vial of Abatacept for injection provides 250-mg Abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg) for administration.
DMARDs: Patients will receive methotrexate or remain on pre-existing conventional synthetic disease-modifying anti-rheumatic drug (DMARD) if already prescribed.
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|---|---|
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DAS-28 CRP Score
|
3.60 score on a scale
Standard Deviation 1.45
|
PRIMARY outcome
Timeframe: Month 6Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP) is a composite index used to assess rheumatoid arthritis (RA) disease activity. The DAS-28 CRP score is calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (scored on 11-point Likert scale from 0 \[no disease activity\] to 10 \[maximum disease activity\]), and high-sensitivity C-reactive protein levels (in mg/L). DAS28-CRP Scores range from 0 to 10; higher scores indicate more active disease.
Outcome measures
| Measure |
Abatacept Plus DMARD
n=18 Participants
Abatacept will be used concomitantly with standard of care disease-modifying anti-rheumatic drugs (DMARDs), other than tumor necrosis factor (TNF) antagonists or Janus kinase (JAK) inhibitors.
Intravenous (IV) Abatacept will be administered as a 30-minute IV infusion utilizing weight range-based dosing:
1. Less than 60 kg: 500 mg
2. 60 to 100 kg: 750 mg
3. More than 100 kg: 1000 mg
Following the initial IV Abatacept administration, an IV infusion will be given at Weeks 2 and 4 after the first infusion and every 4 weeks thereafter for a total of 7 Abatacept doses.
Abatacept will be discontinued after 6 months in all patients. Patients who have flared or failed to achieve low disease activity at 6 months will exit the trial except for one post-study visit for lab work at 9 months. In patients who have achieved low disease activity, Abatacept will be held for 6 months or until a flare results while DMARD use is continued.
Abatacept: Abatacept for reconstitution and dilution prior to intravenous (IV) administration. Each single-use vial of Abatacept for injection provides 250-mg Abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg) for administration.
DMARDs: Patients will receive methotrexate or remain on pre-existing conventional synthetic disease-modifying anti-rheumatic drug (DMARD) if already prescribed.
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|---|---|
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DAS-28 CRP Score
|
2.61 score on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Month 9Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP) is a composite index used to assess rheumatoid arthritis (RA) disease activity. The DAS-28 CRP score is calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (scored on 11-point Likert scale from 0 \[no disease activity\] to 10 \[maximum disease activity\]), and high-sensitivity C-reactive protein levels (in mg/L). DAS28-CRP Scores range from 0 to 10; higher scores indicate more active disease.
Outcome measures
| Measure |
Abatacept Plus DMARD
n=18 Participants
Abatacept will be used concomitantly with standard of care disease-modifying anti-rheumatic drugs (DMARDs), other than tumor necrosis factor (TNF) antagonists or Janus kinase (JAK) inhibitors.
Intravenous (IV) Abatacept will be administered as a 30-minute IV infusion utilizing weight range-based dosing:
1. Less than 60 kg: 500 mg
2. 60 to 100 kg: 750 mg
3. More than 100 kg: 1000 mg
Following the initial IV Abatacept administration, an IV infusion will be given at Weeks 2 and 4 after the first infusion and every 4 weeks thereafter for a total of 7 Abatacept doses.
Abatacept will be discontinued after 6 months in all patients. Patients who have flared or failed to achieve low disease activity at 6 months will exit the trial except for one post-study visit for lab work at 9 months. In patients who have achieved low disease activity, Abatacept will be held for 6 months or until a flare results while DMARD use is continued.
Abatacept: Abatacept for reconstitution and dilution prior to intravenous (IV) administration. Each single-use vial of Abatacept for injection provides 250-mg Abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg) for administration.
DMARDs: Patients will receive methotrexate or remain on pre-existing conventional synthetic disease-modifying anti-rheumatic drug (DMARD) if already prescribed.
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|---|---|
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DAS-28 CRP Score After Abatacept Hold
|
3.14 score on a scale
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: Month 9Clinical Disease Activity Index (CDAI) is a composite index used to assess rheumatoid arthritis (RA) disease activity. The CDAI score is the sum of the Swollen 28-Joint Count (SJC28) + Tender 28-Joint Count (TJC) + Patient Global disease Activity (PGA, patient's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) + Evaluator's Global disease Activity (EGA, evaluator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity). The total score range is 2-76; higher scores (CDAI \> 22) indicate HIgh Disease Activity.
Outcome measures
| Measure |
Abatacept Plus DMARD
n=18 Participants
Abatacept will be used concomitantly with standard of care disease-modifying anti-rheumatic drugs (DMARDs), other than tumor necrosis factor (TNF) antagonists or Janus kinase (JAK) inhibitors.
Intravenous (IV) Abatacept will be administered as a 30-minute IV infusion utilizing weight range-based dosing:
1. Less than 60 kg: 500 mg
2. 60 to 100 kg: 750 mg
3. More than 100 kg: 1000 mg
Following the initial IV Abatacept administration, an IV infusion will be given at Weeks 2 and 4 after the first infusion and every 4 weeks thereafter for a total of 7 Abatacept doses.
Abatacept will be discontinued after 6 months in all patients. Patients who have flared or failed to achieve low disease activity at 6 months will exit the trial except for one post-study visit for lab work at 9 months. In patients who have achieved low disease activity, Abatacept will be held for 6 months or until a flare results while DMARD use is continued.
Abatacept: Abatacept for reconstitution and dilution prior to intravenous (IV) administration. Each single-use vial of Abatacept for injection provides 250-mg Abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg) for administration.
DMARDs: Patients will receive methotrexate or remain on pre-existing conventional synthetic disease-modifying anti-rheumatic drug (DMARD) if already prescribed.
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|---|---|
|
CDAI Score After Abatacept Hold
|
16.83 score on a scale
Standard Deviation 18.84
|
Adverse Events
Abatacept Plus DMARD
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Abatacept Plus DMARD
n=21 participants at risk
Abatacept will be used concomitantly with standard of care disease-modifying anti-rheumatic drugs (DMARDs), other than tumor necrosis factor (TNF) antagonists or Janus kinase (JAK) inhibitors.
Intravenous (IV) Abatacept will be administered as a 30-minute IV infusion utilizing weight range-based dosing:
1. Less than 60 kg: 500 mg
2. 60 to 100 kg: 750 mg
3. More than 100 kg: 1000 mg
Following the initial IV Abatacept administration, an IV infusion will be given at Weeks 2 and 4 after the first infusion and every 4 weeks thereafter for a total of 7 Abatacept doses.
Abatacept will be discontinued after 6 months in all patients. Patients who have flared or failed to achieve low disease activity at 6 months will exit the trial except for one post-study visit for lab work at 9 months. In patients who have achieved low disease activity, Abatacept will be held for 6 months or until a flare results while DMARD use is continued.
Abatacept: Abatacept for reconstitution and dilution prior to intravenous (IV) administration. Each single-use vial of Abatacept for injection provides 250-mg Abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg) for administration.
DMARDs: Patients will receive methotrexate or remain on pre-existing conventional synthetic disease-modifying anti-rheumatic drug (DMARD) if already prescribed.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
URI
|
38.1%
8/21 • Number of events 10 • 9 months
Standard questionnaire at every visit
|
|
Respiratory, thoracic and mediastinal disorders
transient dyspnea-self resolving without treatment
|
4.8%
1/21 • 9 months
Standard questionnaire at every visit
|
|
Skin and subcutaneous tissue disorders
Self-limited rash - transient
|
9.5%
2/21 • 9 months
Standard questionnaire at every visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place