NCT00380744 - A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis | Syfrah

Trials Sponsors Conditions Drugs Pricing

NCT00380744

CompletedPhase 1

A Safety and Pharmacokinetics Study in Participants With Rhe...

Eli Lilly and Company Source

Brief Summary

The purpose of this study is to examine the safety and efficacy of this antibody in participants with rheumatoid arthritis. Part A of the study is an initial dose escalation phase Part B of the study is a randomized allocation of the entire dosing group to parallel treatment assignments

Trial Health

90

On Track

Trial Health Score

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

Enrollment

121

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Nov 2005

Typical duration for phase_1

Geographic Reach

2 countries

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

2 years study duration

Study Start

First participant enrolled

November 1, 2005

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2006

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2006

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed

11.3 years until next milestone

Results Posted

Study results publicly available

February 6, 2019

Completed

Last Updated

February 6, 2019

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

September 22, 2006

Results QC Date

October 21, 2017

Last Update Submit

August 29, 2018

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

Number of Participants With Adverse Events (AEs)
Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of s SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Baseline up to Day 98

Secondary Outcomes (5)

Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval Time 0 to 168 Hours (AUC0-168 hr,ss) of LY2189102
Part A: Day 1 predose and IAI, 2days post infusion, Day 14 and Day 28 predose and IAI, Day 35, 63 (convenient time)
Change From Baseline in Simple Disease Activity Index Score (SDAI)
Baseline, Days 7, 21, 35, 63, and 98
Change From Baseline in Disease Activity Score 28-Joint Count (DAS28)
Baseline, Days 7, 21, 35, 63, and 98
Change From Baseline in C-Reactive Protein (CRP)
Baseline, Days 7, 14, 21, 28, 35, 63, and 98
Change From Baseline in Health Assessment Questionnaire (HAQ) Score
Baseline, Days 35, 63, and 98

Study Arms (5)

Part A LY2189102 0.1 mg/kg/wk

EXPERIMENTAL

Part A: 2 times (x) 0.1 milligrams/kilogram/week (mg/kg/wk) Loading dose, then 0.1 mg/kg/wk) X 4 weeks (wks), intravenous (IV) Part B: 2 x 0.02 mg/kg/wk Loading dose, then 0.02 mg/kg/wk X 4 wks, IV

Drug: LY2189102

Part A LY2189102 0.3 mg/kg/wk

EXPERIMENTAL

Part A: 2 x 0.3 mg/kg/wk Loading dose, then 0.3 mg/kg/wk X 4 wks, IV Part B: 2 x 0.15 mg/kg/wk Loading dose, then 0.15 mg/kg/wk X 4 wks, IV

Drug: LY2189102

Part A LY2189102 1.0 mg/kg/wk

EXPERIMENTAL

Part A: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV Part B: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV

Drug: LY2189102

Part A LY2189102 2.5 mg/kg/wk

EXPERIMENTAL

Part A: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV Part B: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV

Drug: LY2189102

Placebo

PLACEBO COMPARATOR

IV, once weekly x 4 wks

Drug: placebo

Interventions

Part A LY2189102 0.1 mg/kg/wkPart A LY2189102 0.3 mg/kg/wkPart A LY2189102 1.0 mg/kg/wkPart A LY2189102 2.5 mg/kg/wk

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

diagnosis of rheumatoid arthritis
regular use of methotrexate
active rheumatoid arthritis

You may not qualify if:

Juvenile Rheumatoid Arthritis
evidence of tuberculosis
women who are pregnant or become pregnant during study, or are breast-feeding

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.

Tucson, Arizona, 85712, United States

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.

Upland, California, 91786, United States

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.

Miami, Florida, 33169, United States

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.

Port Orange, Florida, 32127, United States

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.

Vero Beach, Florida, 32962, United States

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.

Meridian, Idaho, 83642, United States

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.

Albuquerque, New Mexico, 87102, United States

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.

Mayfield, Ohio, 44143, United States

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.

Bend, Oregon, 97701, United States

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.

Orangeburg, South Carolina, 29118, United States

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.

Bialystok, 15 297, Poland

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.

Szczecin, 71-252, Poland

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.

Warsaw, 02-637, Poland

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.

Wroclaw, 53-137, Poland

Location

Related Publications (1)

Bihorel S, Fiedler-Kelly J, Ludwig E, Sloan-Lancaster J, Raddad E. Population pharmacokinetic modeling of LY2189102 after multiple intravenous and subcutaneous administrations. AAPS J. 2014 Sep;16(5):1009-17. doi: 10.1208/s12248-014-9623-6. Epub 2014 Jun 11.
PMID: 24912797DERIVED

Related Links

Lilly Clinical Trial Registry

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

LY2189102

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 9AM - 5PM 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: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 22, 2006

First Posted

September 26, 2006

Study Start

November 1, 2005

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

February 6, 2019

Results First Posted

February 6, 2019

Record last verified: 2018-08

Locations