NCT01253226

Brief Summary

This study will evaluate the safety and tolerability of multiple doses of LY2127399 (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment period. All participants will be followed for up to 12 weeks after the last study drug administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Sep 2009

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

10 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

September 1, 2009

Completed
1.2 years 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
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

October 23, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

December 1, 2010

Results QC Date

March 24, 2018

Last Update Submit

October 19, 2018

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events (AEs) [Clinically Significant Effects]

    Clinically significant effects are defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.

    Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)

Secondary Outcomes (9)

  • Pharmacokinetics (PK) of Tabalumab: Area Under the Concentration Time Curve (AUC)

    Week 0: Day 1 [predose and 1 hour (h), 3 h, and 6 h postdose], Days 2, 3, and 5, and Weeks 1, 2, 3, and 4 postdose

  • PK of Tabalumab: Maximum Observed Drug Concentration (Cmax)

    Week 0: Day 1 Predose, 1 h, 3 h, and 6 h postdose

  • Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts

    Baseline, Week 0 (Day 2), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, and 32

  • Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody [Inova Enzyme-Linked Immunosorbent Assay (ELISA) Method]

    Baseline, Week 24

  • Change From Baseline in Anti-CCP Antibody (Roche Cobas 6000 Method)

    Baseline, Week 24

  • +4 more secondary outcomes

Study Arms (6)

30 milligrams (mg) Tabalumab

EXPERIMENTAL

30 mg tabalumab every 4 weeks (Q4W) for 20 weeks (6 doses of study drug)

Drug: LY2127399 (Tabalumab)

60 mg Tabalumab

EXPERIMENTAL

60 mg tabalumab Q4W for 20 weeks (6 doses of study drug)

Drug: LY2127399 (Tabalumab)

120 mg Tabalumab

EXPERIMENTAL

120 mg tabalumab Q4W for 20 weeks (6 doses of study drug)

Drug: LY2127399 (Tabalumab)

Placebo Q4W

PLACEBO COMPARATOR

Q4W for 20 weeks

Drug: Placebo

120 mg once every 2 weeks (Q2W) Tabalumab

EXPERIMENTAL

Initial loading dose of 240 mg tabalumab followed by 120 mg Q2W for 20 weeks (10 doses of study drug)

Drug: LY2127399 (Tabalumab)

Placebo Q2W

PLACEBO COMPARATOR

Q2W for 20 weeks

Drug: Placebo

Interventions

LY2127399 (Tabalumab)DRUG

Administered subcutaneously

Also known as: LY2127399, Tabalumab
120 mg Tabalumab120 mg once every 2 weeks (Q2W) Tabalumab30 milligrams (mg) Tabalumab60 mg Tabalumab
PlaceboDRUG

Administered subcutaneously

Placebo Q2WPlacebo Q4W

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
  • Diagnosis of RA
  • Active RA
  • Current, regular use of Methotrexate, at a stable dose
  • Body weight between 40 and 105 kilograms (kg), inclusive

You may not qualify if:

  • Use of excluded medications (reviewed by study doctor)
  • Have medical findings which, in the opinion of the study doctor, put participant at an unacceptable risk for participation in the study
  • Have had recent or ongoing infection which, in the opinion of the study doctor put participant at an unacceptable risk for participation
  • Evidence of tuberculosis
  • Have systemic inflammatory condition other than RA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

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, 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, 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, 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, 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, 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, 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, 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, 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.

Osaka, 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, 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

Limitations and Caveats

The anti-CCP data were difficult to interpret and compare for trends due to the 2 different methods of analysis used and the high variability in the data.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 3, 2010

Study Start

September 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 23, 2018

Results First Posted

October 23, 2018

Record last verified: 2018-10

Locations

JP(10)