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A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

NCT ID: NCT00882999

Last Updated: 2018-11-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-06-30

Brief Summary

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To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12, 16, 20, and 24 weeks compared to placebo.

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Detailed Description

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Conditions

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Relapsing-Remitting Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Injection: Every 4 weeks in the placebo arm for 24 weeks (Weeks 0, 4, 8, 12, 16, and 20) for a total of 6 doses. Every 4 weeks in the LY2127399 arms \[4 milligrams (mg) LY2127399 / 12 weeks and 120 mg LY2127399 / 12 weeks\] for 24 weeks (except Week 0 and Week 12).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered via Injection

4 mg LY2127399 / 4 weeks

Injection: 6 doses, one every 4 weeks for 24 weeks.

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

Administered via Injection

40 mg LY2127399 / 4 weeks

Injection: 6 doses, one every 4 weeks for 24 weeks.

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

Administered via Injection

120 mg LY2127399 / 4 weeks

Injection: 6 doses, one every 4 weeks for 24 weeks.

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

Administered via Injection

4 mg LY2127399 / 12 weeks

Drug: LY2127399 Injection: 2 doses, one every 12 weeks for 24 weeks.

Drug: Placebo Injection: Every 4 weeks for 24 weeks (except Week 0 and Week 12).

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

Administered via Injection

Placebo

Intervention Type DRUG

Administered via Injection

120 mg LY2127399 / 12 weeks

Drug: LY2127399 Injection: 2 doses, one every 12 weeks for 24 weeks.

Drug: Placebo Injection: Every 4 weeks for 24 weeks (except Week 0 and Week 12).

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

Administered via Injection

Placebo

Intervention Type DRUG

Administered via Injection

12 mg LY2127399 / 4 weeks

Injection: 6 doses, one every 4 weeks for 24 weeks.

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

Administered via Injection

Interventions

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LY2127399

Administered via Injection

Intervention Type DRUG

Placebo

Administered via Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 through 64 years of age diagnosed with RRMS, who can walk without aid or rest for at least 200 meters (approximately 1/10 of a mile).
* Women who can become pregnant must use birth control.

Exclusion Criteria

* Have had a live vaccination within 12 weeks before randomization, or intend to have a live vaccination during the course of the study.
* Have had had recent surgery or are scheduled to have surgery during the study.
* Are immunocompromised or have evidence of active infection \[such as hepatitis, tuberculosis or, human immunodeficiency virus (HIV)\].
* Have been on certain drugs that are being studied for RRMS or have recently received prescription drugs to treat RRMS.
* Have had a recent serious infection.
* Have serious or uncontrolled illnesses other than RRMS.
* Have clinically significant blood test values.
* Have multiple or severe drug allergies.
* Have contraindications for MRI "scanning" or claustrophobia (fear of an enclosed space) that cannot be managed.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Phoenix, Arizona, United States

Site Status

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Tucson, Arizona, United States

Site Status

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Fullerton, California, United States

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Denver, Colorado, United States

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Naples, Florida, United States

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Plantation, Florida, United States

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Sarasota, Florida, United States

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Northbrook, Illinois, United States

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Indianapolis, Indiana, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

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Biddeford, Maine, United States

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Farmington Hills, Michigan, United States

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Toms River, New Jersey, United States

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Schenectady, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Akron, Ohio, United States

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Green, Ohio, United States

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Greensburg, Pennsylvania, United States

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Greenville, South Carolina, United States

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Franklin, Tennessee, United States

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Memphis, Tennessee, United States

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Lubbock, Texas, United States

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Round Rock, Texas, United States

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Newport News, Virginia, United States

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Roanoke, Virginia, United States

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Sofia, , Bulgaria

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Brno, , Czechia

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Pardubice, , Czechia

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Prague, , Czechia

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Caen, , France

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Montpellier, , France

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Nîmes, , France

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Strasbourg, , France

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Berlin, , Germany

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Ulm, , Germany

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Budapest, , Hungary

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Győr, , Hungary

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Gyula, , Hungary

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Tel Litwinsky, , Israel

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Gdansk, , Poland

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Gliwice, , Poland

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Grodzisk Mazowiecki, , Poland

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Krakow-Nowa Huta, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Târgu Mureş, , Romania

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Kazan', , Russia

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Kemerovo, , Russia

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Moscow, , Russia

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Belgrade, , Serbia

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Niš, , Serbia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Spišská Nová Ves, , Slovakia

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Žilina, , Slovakia

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Dnipro, , Ukraine

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Donetsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Vinnytsia, , Ukraine

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Zaporizhzhya, , Ukraine

Site Status

Countries

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United States Bulgaria Czechia France Germany Hungary Israel Poland Romania Russia Serbia Slovakia Ukraine

Other Identifiers

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H9B-MC-BCDJ

Identifier Type: OTHER

Identifier Source: secondary_id

12778

Identifier Type: -

Identifier Source: org_study_id

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