Brief Summary

This study is a multicenter, double-blind, study to evaluate the safety and effectiveness of treatment with LY2127399 (in addition to the standard of care treatment, methotrexate) for participants with Rheumatoid Arthritis. Participants will receive three intravenous doses of LY2127399 or placebo. Participants will participate in 10 or more visits to the study site, over 6 months. Evaluation of safety and efficacy will be conducted throughout the study.

Trial Health

On Track

Trial Health Score

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

Enrollment

136

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Mar 2006

Geographic Reach

1 country

14 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

1.6 years study duration

First Submitted

Initial submission to the registry

March 28, 2006

Completed

Same day until next milestone

Study Start

First participant enrolled

March 28, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2007

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2007

Completed

11.4 years until next milestone

Results Posted

Study results publicly available

March 18, 2019

Completed

Last Updated

September 10, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

March 28, 2006

Results QC Date

March 24, 2018

Last Update Submit

August 28, 2019

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Achieving American College of Rheumatology 20% Response (ACR20) (Effectiveness of LY2127399 in Treating Rheumatoid Arthritis Using the ACR20 Scale)
ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), visual analog pain scale, and erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP).
Week 16

Secondary Outcomes (7)

Number of Participants With Treatment Emergent Adverse Events (TEAE) (Safety of Repeat Doses (3) of LY2127399 Through Evaluation of Laboratory Tests, Vital Signs and Electrocardiograms)
Baseline through Study Completion (Up to 19 Months)
Evaluation of the Pharmacokinetics of LY2127399: Clearance
2 hours pre-dose, pre-dose, 1 hour and 4 hour(s) post dose
Percentage of Participants Achieving ACR 50 and ACR70
Baseline through Week 24
Change From Baseline in the Disease Activity Score 28 Joint Count (DAS28-CRP)
Baseline, Week 24
European League Against Rheumatism (EULAR28) Response: Percentage of Participants With Combined Good and Moderate Responses
Baseline, Week 24
+2 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Drug: LY2127399

B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

LY2127399DRUG

30 mg, 60 mg or 160 mg, IV (in the vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.

PlaceboDRUG

IV (in vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female between the ages of 18 and 75 years
Have given written informed consent approval
Women must not be at risk to become pregnant during study participation
Diagnosis of Rheumatoid Arthritis according to the 1987 revised American Rheumatism Association (ARA) criteria for the classification of RA
Serum C-reactive protein (CRP) measurement greater than the upper limit of normal (ULN, 0.574 mg/dL), or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
Current, regular use of Methotrexate, at a stable dose
Biologic DMARD naïve, and have had an insufficient response (in the opinion of the investigator) to an adequate therapeutic dose of at least 1 oral DMARD

You may not qualify if:

Use of excluded medications (reviewed by study doctor)
Surgical treatment of a joint with 2 months of study enrollment that is to be assessed in the study
Are unable to ambulate; that is, confined to bed or wheelchair bound
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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (14)

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.

Bacau, 600114, Romania

Location

Baia Mare, 430031, Romania

Location

Brasov, 500365, Romania

Location

Brăila, 810217, Romania

Location

Bucharest, 024092, Romania

Location

Cluj-Napoca, 400006, Romania

Location

Constanța, 900607, Romania

Location

Craiova, 200322, Romania

Location

Iași, 707061, Romania

Location

Sf. Gheorghe, 520064, Romania

Location

Sibiu, 550245, Romania

Location

Târgovişte, 130083, Romania

Location

Târgu Mureş, 540136, Romania

Location

Timișoara, 300002, Romania

Location

Related Publications (1)

Genovese MC, Bojin S, Biagini IM, Mociran E, Cristei D, Mirea G, Georgescu L, Sloan-Lancaster J. Tabalumab in rheumatoid arthritis patients with an inadequate response to methotrexate and naive to biologic therapy: a phase II, randomized, placebo-controlled trial. Arthritis Rheum. 2013 Apr;65(4):880-9. doi: 10.1002/art.37820.
PMID: 23359344DERIVED

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

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 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 29, 2006

Study Start

March 28, 2006

Primary Completion

June 18, 2007

Study Completion

October 18, 2007

Last Updated

September 10, 2019

Results First Posted

March 18, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

RO(14)

A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Participants With Rheumatoid Arthritis

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (14)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (14)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations