NCT01253291

Brief Summary

The objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior LY2127399 clinical study. At the end of the 48-week treatment period, participants will participate in a 24-week follow-up period. Additional follow up after Week 72 may continue to assess B-cell recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started May 2010

Longer than P75 for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
5 years until next milestone

Results Posted

Study results publicly available

March 1, 2019

Completed
Last Updated

March 1, 2019

Status Verified

October 1, 2018

Enrollment Period

3.3 years

First QC Date

December 1, 2010

Results QC Date

March 24, 2018

Last Update Submit

October 29, 2018

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module.

    Baseline up to 72 weeks

Secondary Outcomes (7)

  • Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody

    Baseline and Weeks 12, 24, 36, 52, and 72

  • Percent Change From Baseline in Rheumatoid Factor (RF)

    Baseline and Weeks 12, 24, 36, 52, and 72

  • Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA]

    Baseline and Weeks 12, 24, 36, 52, and 72

  • Percent Change From Baseline in CD20+ B-cell Count

    Baseline and Weeks 12, 24, 36, 52, and 72

  • Percent Change From Baseline in Peripheral B-cell Subsets

    Baseline and Weeks 12, 24, 36, 52, and 72

  • +2 more secondary outcomes

Study Arms (2)

30mg/120 mg LY2127399

EXPERIMENTAL

Participants in the 30 milligrams (mg) every 4 weeks arm of the lead-in study will receive 30 mg every 4 weeks until the safety of the 120 mg every 4 weeks dose is confirmed in the lead-in study.

Drug: LY2127399

120 mg LY2127399

EXPERIMENTAL

Participants in the 60 mg every 4 weeks, 120 mg every 4 weeks and 120 mg every 2 weeks arms of the lead-in study will receive 120 mg every 4 weeks as these participants will enroll in this study after the safety of the 120 mg every 4 weeks dose in the lead-in study is confirmed.

Drug: LY2127399

Interventions

LY2127399DRUG

Administered subcutaneously every 4 weeks for 48 weeks

Also known as: tabalumab
120 mg LY212739930mg/120 mg LY2127399

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have given written informed consent
  • Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
  • Must have completed treatment and 12 week follow up period in prior LY2127399 study NCT01253226 \[Study H9B-JE-BCDK (BCDK)\]

You may not qualify if:

  • Have had any safety event during the previous LY2127399 (BCDK) study that participants participated in
  • Have received, during previous study (BCDK), any drugs prohibited in the study protocol which includes unapproved drugs, live vaccines, or any biologic or non-biologic disease-modifying anti-rheumatic drug (DMARD) except for, methotrexate (MTX), hydroxychloroquine, sulfasalazine or bucillamine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

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.

Aichi, 460-0001, Japan

Location

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.

Chiba, 2892511, Japan

Location

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.

Fukui, 910-0067, Japan

Location

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.

Gunma, 370-0053, Japan

Location

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.

Hyōgo, 673-1462, Japan

Location

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.

Ibaraki, 311-3516, Japan

Location

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.

Kanagawa, 252-0392, Japan

Location

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.

Miyagi, 982-0032, Japan

Location

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.

Tokyo, 152-8902, Japan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tabalumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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 DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 3, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2013

Study Completion

March 1, 2014

Last Updated

March 1, 2019

Results First Posted

March 1, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

JP(9)