Trial Outcomes & Findings for Evaluation of Tabalumab Using Auto-Injector or Prefilled Syringe in Participants With Rheumatoid Arthritis (RA) (NCT NCT01676701)
NCT ID: NCT01676701
Last Updated: 2018-04-26
Results Overview
TERMINATED
PHASE3
8 participants
Days 4, 7, 9, 11, and 14 after loading dose administered
2018-04-26
Participant Flow
The study was to include a 12-week treatment period, optional 40-week safety extension, and post-treatment follow-up (at least 24 weeks). At the time of early study termination, all participants who had received tabalumab discontinued dosing and then completed the post-treatment follow-up period. No one entered the 40-week safety extension period.
Participant milestones
| Measure |
Tabalumab Auto-Injector
Tabalumab: Using auto-injectors, participants received a 180 milligram (mg) loading dose at Week 0 as 2 subcutaneous (SC) injections (90 mg each). Participants also received a 90 mg SC injection every 2 weeks (Q2W) until early study termination (up to Week 6).
|
Tabalumab Prefilled Syringe
Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
4
|
4
|
|
Overall Study
Completed Post-Treatment Follow-Up
|
4
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Tabalumab Auto-Injector
Tabalumab: Using auto-injectors, participants received a 180 milligram (mg) loading dose at Week 0 as 2 subcutaneous (SC) injections (90 mg each). Participants also received a 90 mg SC injection every 2 weeks (Q2W) until early study termination (up to Week 6).
|
Tabalumab Prefilled Syringe
Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Sponsor Decision
|
3
|
4
|
Baseline Characteristics
Evaluation of Tabalumab Using Auto-Injector or Prefilled Syringe in Participants With Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
Tabalumab Auto-Injector
n=4 Participants
Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
|
Tabalumab Prefilled Syringe
n=4 Participants
Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
43.3 to 65.4 years
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 4, 7, 9, 11, and 14 after loading dose administeredPopulation: No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Days 4, 7, 9, 11, and 14 after loading dose administeredPopulation: No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12Population: No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 4 and 8Population: No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.
Outcome measures
Outcome data not reported
Adverse Events
Tabalumab Auto-Injector (Treatment Period)
Tabalumab Auto-Injector (Post Treatment Follow-Up Period)
Tabalumab Prefilled Syringe (Treatment Period)
Tabalumab Prefilled Syringe (Post Treatment Follow-Up Period)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tabalumab Auto-Injector (Treatment Period)
n=4 participants at risk
Tabalumab: Using auto-injectors, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
|
Tabalumab Auto-Injector (Post Treatment Follow-Up Period)
n=4 participants at risk
No study drug was administered during the Post-Treatment Follow-Up Period for participants in the Tabalumab Auto-Injector treatment arm.
|
Tabalumab Prefilled Syringe (Treatment Period)
n=4 participants at risk
Tabalumab: Using prefilled syringes, participants received a 180 mg loading dose administered at Week 0 as 2 SC injections (90 mg each). Participants also received a 90 mg SC injection Q2W until early study termination (up to Week 6).
|
Tabalumab Prefilled Syringe (Post Treatment Follow-Up Period)
n=4 participants at risk
No study drug was administered during the Post-Treatment Follow-Up Period for participants in the Tabalumab Prefilled Syringe treatment arm.
|
|---|---|---|---|---|
|
Infections and infestations
Gastric Infection
|
0.00%
0/4 • Baseline up to Week 12 or early termination (Treatment Period) and last dose up to 24 weeks post last dose (Post-Treatment Follow-Up Period)
|
25.0%
1/4 • Baseline up to Week 12 or early termination (Treatment Period) and last dose up to 24 weeks post last dose (Post-Treatment Follow-Up Period)
|
0.00%
0/4 • Baseline up to Week 12 or early termination (Treatment Period) and last dose up to 24 weeks post last dose (Post-Treatment Follow-Up Period)
|
0.00%
0/4 • Baseline up to Week 12 or early termination (Treatment Period) and last dose up to 24 weeks post last dose (Post-Treatment Follow-Up Period)
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60