A Study of LY2127399 in Rheumatoid Arthritis

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01576549
• Collaborator: (none)
• Enrollment: 2
• Locations: 4
• Arm: 1
• Duration (Months): 12
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This study will investigate how LY2127399 works in participants with rheumatoid arthritis (RA) who are not adequately responding to methotrexate. Participants will receive LY2127399 via an injection(s) under the skin at 4 week intervals for up to 52 weeks. Key study procedures include biopsies of the lining of an inflamed joint and blood tests to measure RA activity.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: LY2127399	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Exploratory Open-Label Biomarker Study of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Synovial Biopsies
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY2127399 LY2127399 given subcutaneously (SC) at 240 milligrams (mg) as a loading dose in the first week followed by 120 mg SC every 4 weeks for up to 52 weeks.	Drug: LY2127399; Administered subcutaneously; Other Names: tabalumab

Outcome Measures

Primary Outcome Measures

1. Percent Change in Synovitis Scores From Baseline up to Week 16 [Baseline up to Week 16]

   Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.

2. Percent Change in Synovial B Cell Mass From Baseline up to Week 16 [Baseline up to Week 16]

   Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.

3. Percent Change in Synovial Immunoglobulin (Ig) Synthesis From Baseline up to Week 16 [Baseline up to Week 16]

   Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.

Secondary Outcome Measures

1. Percent Change in Various Cell Types in the Blood From Baseline up to Week 24 [Baseline up to Week 24]

   Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of adult onset RA disease according to revised 1987 American Rheumatism Association (ARA) criteria and currently have a documented history of positive for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (anti-CCP Ab) and have moderately to severely active RA despite ongoing methotrexate (MTX) therapy

• Have active RA defined as the presence of at least 8/68 tender and at least 8/66 swollen joints, as determined by the tender joint count and swollen joint count assessment forms

• Have a screening C-reactive protein (CRP) measurement greater than 1.2 times upper limit of normal or erythrocyte sedimentation rate (ESR) greater than 28 millimeters/hour (mm/hr)

• Have a clinically inflamed joint suitable for synovial biopsy procedure

Exclusion Criteria:

• Have used an unstable dose of non-steroidal anti-inflammatory drugs (NSAIDs) within 6 weeks prior to baseline

• Have used oral corticosteroids at average daily doses of >10 milligrams/day (mg/day) of prednisone or its equivalent within 6 weeks prior to baseline

• Have received any parenteral corticosteroid injection within 6 weeks of baseline

• Have used other disease-modifying anti-rheumatic drugs (DMARDs) other than MTX, hydroxychloroquine, and/or sulfasalazine in the 8 weeks prior to baseline

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Frederick	Maryland	United States	21702
2	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Battle Creek	Michigan	United States	49015
3	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mayfield	Ohio	United States	44143
4	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mesquite	Texas	United States	75150

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01576549
• Other Study ID Numbers: 14319; H9B-MC-BCEE
• First Posted: Apr 12, 2012
• Last Update Posted: Apr 26, 2018
• Last Verified: Mar 1, 2018

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

Participant Flow

Arm/Group Title	LY2127399
Arm/Group Description	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.
Period Title: Overall Study
STARTED	2
Received at Least 1 Dose of Study Drug	2
Completed Post-Treatment Follow-Up	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	LY2127399
Arm/Group Description	Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
Overall Participants	2
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	66
Sex: Female, Male (Count of Participants)
Female	2 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	2 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	2 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Percent Change in Synovitis Scores From Baseline up to Week 16
Description	Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.

Arm/Group Title	LY2127399
Arm/Group Description	Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
Measure Participants	0

2. Primary Outcome

Title	Percent Change in Synovial B Cell Mass From Baseline up to Week 16
Description	Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.

Arm/Group Title	LY2127399
Arm/Group Description	Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
Measure Participants	0

3. Primary Outcome

Title	Percent Change in Synovial Immunoglobulin (Ig) Synthesis From Baseline up to Week 16
Description	Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.

Arm/Group Title	LY2127399
Arm/Group Description	Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
Measure Participants	0

4. Secondary Outcome

Title	Percent Change in Various Cell Types in the Blood From Baseline up to Week 24
Description	Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Time Frame	Baseline up to Week 24

Outcome Measure Data

Analysis Population Description

No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.

Arm/Group Title	LY2127399
Arm/Group Description	Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.
Measure Participants	0

Adverse Events

Arm/Group Title	LY2127399 - Treatment Period		LY2127399 - Follow-up Period
Arm/Group Description	Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1.		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.
All Cause Mortality
	LY2127399 - Treatment Period		LY2127399 - Follow-up Period
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	LY2127399 - Treatment Period		LY2127399 - Follow-up Period
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		1/2 (50%)
Infections and infestations
Pneumonia	0/2 (0%)	0	1/2 (50%)	1
Respiratory, thoracic and mediastinal disorders
Pneumothorax	1/2 (50%)	2	0/2 (0%)	0
Vascular disorders
Hypotension	0/2 (0%)	0	1/2 (50%)	1
Other (Not Including Serious) Adverse Events
	LY2127399 - Treatment Period		LY2127399 - Follow-up Period
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		1/2 (50%)
Blood and lymphatic system disorders
Leukocytosis	1/2 (50%)	1	0/2 (0%)	0
Metabolism and nutrition disorders
Hypercalcaemia	1/2 (50%)	1	0/2 (0%)	0
Hyperglycaemia	1/2 (50%)	1	0/2 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	1/2 (50%)	1	0/2 (0%)	0
Nervous system disorders
Dizziness	1/2 (50%)	1	0/2 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumothorax	1/2 (50%)	1	1/2 (50%)	1
Skin and subcutaneous tissue disorders
Rosacea	1/2 (50%)	1	0/2 (0%)	0
Vascular disorders
Deep vein thrombosis	0/2 (0%)	0	1/2 (50%)	1

Limitations/Caveats

Due to early termination of the trial (February 2013 in conjunction with the FLEX RA program), no participant had outcome measure data analyzed. Participants who received study treatment had disposition, demographic, and adverse event data reported.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.