Trial Outcomes & Findings for A Study of LY2127399 in Rheumatoid Arthritis (NCT NCT01576549)
NCT ID: NCT01576549
Last Updated: 2018-04-26
Results Overview
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
TERMINATED
PHASE2
2 participants
Baseline up to Week 16
2018-04-26
Participant Flow
Participant milestones
| Measure |
LY2127399
Participants received 240 milligrams (mg) LY2127399 administered subcutaneously (SC) (2 SC injections of 120 mg) as a loading dose on Day 1.
Follow-up visits occurred up to 24 weeks after the final injection of study drug.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
2
|
|
Overall Study
Completed Post-Treatment Follow-Up
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
LY2127399
Participants received 240 milligrams (mg) LY2127399 administered subcutaneously (SC) (2 SC injections of 120 mg) as a loading dose on Day 1.
Follow-up visits occurred up to 24 weeks after the final injection of study drug.
|
|---|---|
|
Overall Study
Sponsor Decision
|
2
|
Baseline Characteristics
A Study of LY2127399 in Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
LY2127399
n=2 Participants
Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
|
|---|---|
|
Age, Continuous
|
66 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 16Population: No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to Week 16Population: No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to Week 16Population: No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Outcome measures
Outcome data not reported
Adverse Events
LY2127399 - Treatment Period
LY2127399 - Follow-up Period
Serious adverse events
| Measure |
LY2127399 - Treatment Period
n=2 participants at risk
Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
|
LY2127399 - Follow-up Period
n=2 participants at risk
Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
Participants then discontinued dosing as a result of study closure, but completed the Post-Treatment Follow-Up Period for up to 24 weeks after the final injection of study drug.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
50.0%
1/2 • Number of events 2
|
0.00%
0/2
|
|
Vascular disorders
Hypotension
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
Other adverse events
| Measure |
LY2127399 - Treatment Period
n=2 participants at risk
Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
|
LY2127399 - Follow-up Period
n=2 participants at risk
Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
Participants then discontinued dosing as a result of study closure, but completed the Post-Treatment Follow-Up Period for up to 24 weeks after the final injection of study drug.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
50.0%
1/2 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2
|
50.0%
1/2 • Number of events 1
|
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