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An Open Label Study for Participants With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

LY2127399

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have completed 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM
Woman must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion Criteria:

Current presence of a serious disorder or illness

Sites / Locations

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.
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

120 milligrams (mg) of LY2127399

90 mg LY2127399

Arm Description

Given every 4 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 240 mg loading dose when initiating treatment. Or Given every 4 weeks for 168 weeks for those participants from Study BCDM.

Given every 2 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 180 mg loading dose when initiating treatment. Or Given every 2 weeks for 168 weeks for those participants from Study BCDM.

Outcomes

Primary Outcome Measures

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period

A TEAE was defined as an event that first occurred or worsened in severity on or after the date of the first injection and prior to study termination. AESI are infection, injection site reactions, malignancy, major adverse cardiovascular events (MACE), allergy and hypersensitivity, depression, suicide/self-injury and pregnancy. MACE were defined as 1 of the adjudicated events: cardiovascular death, Myocardial infarction (MI), stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure, peripheral revascularization procedure, cardiogenic shock due to MI, resuscitated sudden death, serious arrhythmia, hospitalization for hypertension, peripheral arterial event. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Percentage of Participants Developing Anti-LY2127399 Antibodies

Participants with treatment-emergent anti-LY2127399 antibodies were participants who had any samples from baseline up to and through Week 72 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants with anti-LY2127399 antibodies=(number of participants with treatment-emergent anti-LY2127399 antibodies / number of participants assessed)*100.

Change From Baseline in Absolute B Cell Counts

Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B cell count is the average of the values on or prior to the date of first injection of study treatment in preceding studies, including unscheduled visits. A positive or negative change indicated an increase or decrease, respectively, in B cell count.

Change From Baseline in Serum Immunoglobulin (Ig) Levels

Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin A (IgA), immunoglobulin G (IgG), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP.

Secondary Outcome Measures

Percentage of Participants With American College of Rheumatology 20% Response (ACR20)

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 68 tender and 66 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), joint pain, and C-reactive protein (CRP). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of LY2127399 in preceding studies or Study BCDP. Percentage of participants achieving ACR20 response=(number of ACR20 responders / number of participants treated) * 100. All participants who discontinue study treatment for any reason were defined as NR at that time point and going forward.

Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)

Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR-28) Response

Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores

Change From Baseline in Tender Joint Count (68 Joint Count)

Change From Baseline in Swollen Joint Count (66 Joint Count)

Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]

Change From Baseline in Participants Global Assessment of Disease Activity (VAS)

Change From Baseline in Physicians Global Assessment of Disease Activity (VAS)

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)

Change From Baseline in CRP

American College of Rheumatology Percent Improvement (ACR-N)

Full Information

NCT ID

NCT01215942

First Posted

October 5, 2010

Last Updated

May 11, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01215942

Brief Title

An Open Label Study for Participants With Rheumatoid Arthritis

Official Title

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Terminated

Why Stopped

Insufficient efficacy observed in study BCDM (NCT01198002) and BCDV (NCT01202773).

Study Start Date

June 2011 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in participants with Rheumatoid Arthritis. This study is comprised of 2 periods: Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002). Period 2: 48-week post-treatment follow-up

Detailed Description

Week 16 non-responders (NR) are participants with <20% improvement from baseline in both tender and swollen joint counts when assessed at Week 16 of Studies BCDO, BCDV and BCDM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1086 (Actual)

8. Arms, Groups, and Interventions

Arm Title

120 milligrams (mg) of LY2127399

Arm Type

Experimental

Arm Description

Arm Title

90 mg LY2127399

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

LY2127399

Other Intervention Name(s)

Tabalumab

Intervention Description

Administered Subcutaneously

Primary Outcome Measure Information:

Title

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)During Treatment Period

Description

Time Frame

up to 84.4 weeks during treatment period

Title

Percentage of Participants Developing Anti-LY2127399 Antibodies

Description

Time Frame

Baseline through Weeks 4, 24, 48 and 72

Title

Change From Baseline in Absolute B Cell Counts

Description

Time Frame

Baseline, Week 48

Title

Change From Baseline in Serum Immunoglobulin (Ig) Levels

Description

Time Frame

Baseline, Week 48

Secondary Outcome Measure Information:

Title

Percentage of Participants With American College of Rheumatology 20% Response (ACR20)

Description

Time Frame

Baseline through Weeks 12, 24 and 48

Title

Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)

Time Frame

Baseline, 240 weeks

Title

Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR-28) Response

Time Frame

Baseline through 240 weeks

Title

Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores

Time Frame

Baseline, 240 weeks

Title

Change From Baseline in Tender Joint Count (68 Joint Count)

Time Frame

Baseline, 240 weeks

Title

Change From Baseline in Swollen Joint Count (66 Joint Count)

Time Frame

Baseline, 240 weeks

Title

Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]

Time Frame

Baseline, 240 weeks

Title

Change From Baseline in Participants Global Assessment of Disease Activity (VAS)

Time Frame

Baseline, 240 weeks

Title

Change From Baseline in Physicians Global Assessment of Disease Activity (VAS)

Time Frame

Baseline, 240 weeks

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)

Time Frame

Baseline, 240 weeks

Title

Change From Baseline in CRP

Time Frame

Baseline, 240 weeks

Title

American College of Rheumatology Percent Improvement (ACR-N)

Time Frame

Baseline through 240 weeks

Other Pre-specified Outcome Measures:

Title

Number of Participants Who Died During Treatment Period and Post-Treatment Follow-Up Period

Time Frame

Up to 84.4 weeks during treatment period and discontinuation from study treatment up to 48 weeks during follow-up period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have completed 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM Woman must not be pregnant, breastfeeding, or become pregnant during the study Exclusion Criteria: Current presence of a serious disorder or illness

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UCT/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35810

Country

United States

Facility Name

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

Facility Name

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Facility Name

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

City

Escondido

State/Province

California

ZIP/Postal Code

92027

Country

United States

Facility Name

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

City

Hemet

State/Province

California

ZIP/Postal Code

92543

Country

United States

Facility Name

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92646

Country

United States

Facility Name

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Facility Name

City

Long Beach

State/Province

California

ZIP/Postal Code

90808

Country

United States

Facility Name

City

Los Angeles

State/Province

California

ZIP/Postal Code

90022

Country

United States

Facility Name

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

City

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

Facility Name

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

City

Wildomar

State/Province

California

ZIP/Postal Code

92595

Country

United States

Facility Name

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80910

Country

United States

Facility Name

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

City

Lewes

State/Province

Delaware

ZIP/Postal Code

19958

Country

United States

Facility Name

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33472

Country

United States

Facility Name

City

DeBary

State/Province

Florida

ZIP/Postal Code

32713

Country

United States

Facility Name

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33716

Country

United States

Facility Name

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

City

Venice

State/Province

Florida

ZIP/Postal Code

34292

Country

United States

Facility Name

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

City

Zephyrhills

State/Province

Florida

ZIP/Postal Code

33542

Country

United States

Facility Name

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

City

Dunwoody

State/Province

Georgia

ZIP/Postal Code

30338

Country

United States

Facility Name

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30045

Country

United States

Facility Name

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31405

Country

United States

Facility Name

City

Stockbridge

State/Province

Georgia

ZIP/Postal Code

30281

Country

United States

Facility Name

City

Eagle

State/Province

Idaho

ZIP/Postal Code

83616

Country

United States

Facility Name

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

City

Morton Grove

State/Province

Illinois

ZIP/Postal Code

60053

Country

United States

Facility Name

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61636

Country

United States

Facility Name

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61103

Country

United States

Facility Name

City

Brownsburg

State/Province

Indiana

ZIP/Postal Code

46112

Country

United States

Facility Name

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46227

Country

United States

Facility Name

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

City

Shawnee Mission

State/Province

Kansas

ZIP/Postal Code

66218

Country

United States

Facility Name

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67208

Country

United States

Facility Name

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42303

Country

United States

Facility Name

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

City

Haverhill

State/Province

Massachusetts

ZIP/Postal Code

01830

Country

United States

Facility Name

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

City

Bingham Farms

State/Province

Michigan

ZIP/Postal Code

48025

Country

United States

Facility Name

City

Saint Clair Shores

State/Province

Michigan

ZIP/Postal Code

48081

Country

United States

Facility Name

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

City

Florissant

State/Province

Missouri

ZIP/Postal Code

63031

Country

United States

Facility Name

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63131

Country

United States

Facility Name

City

Kalispell

State/Province

Montana

ZIP/Postal Code

59901

Country

United States

Facility Name

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

City

Nashua

State/Province

New Hampshire

ZIP/Postal Code

03060

Country

United States

Facility Name

City

Berkeley Heights

State/Province

New Jersey

ZIP/Postal Code

07922

Country

United States

Facility Name

City

Clifton

State/Province

New Jersey

ZIP/Postal Code

07012

Country

United States

Facility Name

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87108

Country

United States

Facility Name

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

City

Roslyn

State/Province

New York

ZIP/Postal Code

11576

Country

United States

Facility Name

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

City

Sanford

State/Province

North Carolina

ZIP/Postal Code

27330

Country

United States

Facility Name

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58502

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

City

Bend

State/Province

Oregon

ZIP/Postal Code

97701

Country

United States

Facility Name

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18017

Country

United States

Facility Name

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16508

Country

United States

Facility Name

City

Limerick

State/Province

Pennsylvania

ZIP/Postal Code

19468

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19152

Country

United States

Facility Name

City

Pottstown

State/Province

Pennsylvania

ZIP/Postal Code

19464

Country

United States

Facility Name

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

Country

United States

Facility Name

City

North Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

City

Taylors

State/Province

South Carolina

ZIP/Postal Code

29687

Country

United States

Facility Name

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

City

Lake Jackson

State/Province

Texas

ZIP/Postal Code

77566

Country

United States

Facility Name

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79424

Country

United States

Facility Name

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

City

Nassau Bay

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

City

North Richland Hills

State/Province

Texas

ZIP/Postal Code

76180

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77478

Country

United States

Facility Name

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Facility Name

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23225

Country

United States

Facility Name

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

City

Wenatchee

State/Province

Washington

ZIP/Postal Code

98801

Country

United States

Facility Name

City

Clarksburg

State/Province

West Virginia

ZIP/Postal Code

26301

Country

United States

Facility Name

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

City

Racine

State/Province

Wisconsin

ZIP/Postal Code

53406

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

City

Córdoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

City

Lujan

ZIP/Postal Code

6700

Country

Argentina

Facility Name

City

Mar Del Plata

ZIP/Postal Code

B7600FZN

Country

Argentina

Facility Name

City

Quilmes

ZIP/Postal Code

B1878DVC

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

2000

Country

Argentina

Facility Name

City

San Juan

ZIP/Postal Code

5400

Country

Argentina

Facility Name

City

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

City

Campbelltown

State/Province

New South Wales

ZIP/Postal Code

2560

Country

Australia

Facility Name

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

04266-010

Country

Australia

Facility Name

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

City

Malvern East

ZIP/Postal Code

3145

Country

Australia

Facility Name

City

Campinas

ZIP/Postal Code

13059-000

Country

Brazil

Facility Name

City

Caxias Do Sul

ZIP/Postal Code

95070-560

Country

Brazil

Facility Name

City

Curitiba

ZIP/Postal Code

80060-240

Country

Brazil

Facility Name

City

Fortaleza

ZIP/Postal Code

60150-170

Country

Brazil

Facility Name

City

Juiz De Fora

ZIP/Postal Code

36010-570

Country

Brazil

Facility Name

City

Rio De Janeiro

ZIP/Postal Code

20551-030

Country

Brazil

Facility Name

City

Setor Oeste/Goiania

ZIP/Postal Code

74110-129

Country

Brazil

Facility Name

City

São Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

City

Burgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

City

Plovdiv

ZIP/Postal Code

4003

Country

Bulgaria

Facility Name

City

Rousse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

City

Sevlievo

ZIP/Postal Code

5400

Country

Bulgaria

Facility Name

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

City

Bogota

Country

Colombia

Facility Name

City

Medellin

Country

Colombia

Facility Name

City

Opatija

ZIP/Postal Code

51410

Country

Croatia

Facility Name

City

Osijek

ZIP/Postal Code

31000

Country

Croatia

Facility Name

City

Rijeka

ZIP/Postal Code

HR-51000

Country

Croatia

Facility Name

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

City

Orleans

ZIP/Postal Code

45000

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75022

Country

France

Facility Name

City

Saint-Etienne Cedex 02

ZIP/Postal Code

42055

Country

France

Facility Name

City

Strasbourg

ZIP/Postal Code

67 098

Country

France

Facility Name

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

City

Bad Doberan

ZIP/Postal Code

18209

Country

Germany

Facility Name

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

City

Baden-Baden

ZIP/Postal Code

76530

Country

Germany

Facility Name

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

City

Koeln

ZIP/Postal Code

50924

Country

Germany

Facility Name

City

Munich

ZIP/Postal Code

80639

Country

Germany

Facility Name

City

Haidari/Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

City

Larissa

ZIP/Postal Code

411 10

Country

Greece

Facility Name

City

Thessaloniki

ZIP/Postal Code

54636

Country

Greece

Facility Name

City

Baja

ZIP/Postal Code

6500

Country

Hungary

Facility Name

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

City

Esztergom

ZIP/Postal Code

2500

Country

Hungary

Facility Name

City

Kiskunhalas

ZIP/Postal Code

6400

Country

Hungary

Facility Name

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

City

Satoraljaujhely

ZIP/Postal Code

3980

Country

Hungary

Facility Name

City

Szikszo

ZIP/Postal Code

3800

Country

Hungary

Facility Name

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

City

Ahmedabad

ZIP/Postal Code

3800015

Country

India

Facility Name

City

Bangalore

ZIP/Postal Code

5600092

Country

India

Facility Name

City

Chennai

ZIP/Postal Code

600100

Country

India

Facility Name

City

Hyderabaad

ZIP/Postal Code

500082

Country

India

Facility Name

City

Jaipur

ZIP/Postal Code

302023

Country

India

Facility Name

City

Lucknow

ZIP/Postal Code

226 014

Country

India

Facility Name

City

Mysore

ZIP/Postal Code

570023

Country

India

Facility Name

City

Nellore

ZIP/Postal Code

524003

Country

India

Facility Name

City

New Delhi

ZIP/Postal Code

110 076

Country

India

Facility Name

City

Secunderabad

ZIP/Postal Code

500 003

Country

India

Facility Name

City

Surat

ZIP/Postal Code

395003

Country

India

Facility Name

City

Aichi

ZIP/Postal Code

460-0001

Country

Japan

Facility Name

City

Chiba

ZIP/Postal Code

260-8712

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

807-8555

Country

Japan

Facility Name

City

Gunma

ZIP/Postal Code

370-0053

Country

Japan

Facility Name

City

Hokkaido

ZIP/Postal Code

063-0811

Country

Japan

Facility Name

City

Hyogo

ZIP/Postal Code

650-0017

Country

Japan

Facility Name

City

Ibaragi

ZIP/Postal Code

316-0035

Country

Japan

Facility Name

City

Ibaraki

ZIP/Postal Code

305-8576

Country

Japan

Facility Name

City

Japan

ZIP/Postal Code

275-0006

Country

Japan

Facility Name

City

Kagoshima

ZIP/Postal Code

891-0133

Country

Japan

Facility Name

City

Kanagawa

ZIP/Postal Code

252-0392

Country

Japan

Facility Name

City

Kumamoto

ZIP/Postal Code

861-8520

Country

Japan

Facility Name

City

Mie

ZIP/Postal Code

514-1101

Country

Japan

Facility Name

City

Miyagi

ZIP/Postal Code

982-0032

Country

Japan

Facility Name

City

Miyazaki

ZIP/Postal Code

880-0122

Country

Japan

Facility Name

City

Nagano

ZIP/Postal Code

380-8582

Country

Japan

Facility Name

City

Nagasaki

ZIP/Postal Code

857-1195

Country

Japan

Facility Name

City

Nara

ZIP/Postal Code

634-0007

Country

Japan

Facility Name

City

Ohita

ZIP/Postal Code

874-0011

Country

Japan

Facility Name

City

Okayama

ZIP/Postal Code

710-0016

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

586-8521

Country

Japan

Facility Name

City

Saga

ZIP/Postal Code

843-0393

Country

Japan

Facility Name

City

Saitama

ZIP/Postal Code

337-0012

Country

Japan

Facility Name

City

Sapporo-Shi

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

City

Shizuoka

ZIP/Postal Code

420-8623

Country

Japan

Facility Name

City

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

113-0034

Country

Japan

Facility Name

City

Toyama

ZIP/Postal Code

933-0874

Country

Japan

Facility Name

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

Facility Name

City

Daegu

ZIP/Postal Code

700-721

Country

Korea, Republic of

Facility Name

City

Daejeon

ZIP/Postal Code

301-721

Country

Korea, Republic of

Facility Name

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

City

Seongnam-Si

ZIP/Postal Code

463-707

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

143-729

Country

Korea, Republic of

Facility Name

City

Suwon-City

ZIP/Postal Code

442-721

Country

Korea, Republic of

Facility Name

City

Alytus

ZIP/Postal Code

62114

Country

Lithuania

Facility Name

City

Kaunas

ZIP/Postal Code

49475

Country

Lithuania

Facility Name

City

Klaipedos

ZIP/Postal Code

92288

Country

Lithuania

Facility Name

City

Siauliai

ZIP/Postal Code

73231

Country

Lithuania

Facility Name

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

City

Batu Caves

ZIP/Postal Code

68100

Country

Malaysia

Facility Name

City

Kota Bahru

ZIP/Postal Code

15586

Country

Malaysia

Facility Name

City

Kuantan Pahang

ZIP/Postal Code

25100

Country

Malaysia

Facility Name

City

Perak

ZIP/Postal Code

30990

Country

Malaysia

Facility Name

City

Putrajaya

ZIP/Postal Code

62250

Country

Malaysia

Facility Name

City

Sarawak

ZIP/Postal Code

93586

Country

Malaysia

Facility Name

City

Aguascalientes

ZIP/Postal Code

20000

Country

Mexico

Facility Name

City

Barrio San Mateo

ZIP/Postal Code

52140

Country

Mexico

Facility Name

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

City

Guadalajara

ZIP/Postal Code

44690

Country

Mexico

Facility Name

City

Mexicali

ZIP/Postal Code

21100

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

03720

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

City

Morelia

ZIP/Postal Code

58070

Country

Mexico

Facility Name

City

Queretaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

City

San Luis Potosi

ZIP/Postal Code

78200

Country

Mexico

Facility Name

City

Tijuana

ZIP/Postal Code

22010

Country

Mexico

Facility Name

City

Hamilton

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

City

Rotorua

ZIP/Postal Code

3010

Country

New Zealand

Facility Name

City

Tauranga

ZIP/Postal Code

3140

Country

New Zealand

Facility Name

City

Timaru

Country

New Zealand

Facility Name

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

City

Dzialdowo

ZIP/Postal Code

13-200

Country

Poland

Facility Name

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

City

Gdynia

ZIP/Postal Code

81-384

Country

Poland

Facility Name

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-607

Country

Poland

Facility Name

City

Plock

ZIP/Postal Code

09-400

Country

Poland

Facility Name

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

01-192

Country

Poland

Facility Name

City

Wloszczowa

ZIP/Postal Code

29-100

Country

Poland

Facility Name

City

Brasov

ZIP/Postal Code

500365

Country

Romania

Facility Name

City

Cluj-Napoca

ZIP/Postal Code

400130

Country

Romania

Facility Name

City

Iasi

ZIP/Postal Code

700656

Country

Romania

Facility Name

City

Ploiesti

ZIP/Postal Code

100337

Country

Romania

Facility Name

City

Barnaul

ZIP/Postal Code

656038

Country

Russian Federation

Facility Name

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Facility Name

City

Khanty-Mansiysk

ZIP/Postal Code

628012

Country

Russian Federation

Facility Name

City

Kursk

ZIP/Postal Code

305007

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

125299

Country

Russian Federation

Facility Name

City

Nizhny Novgorod

ZIP/Postal Code

603005

Country

Russian Federation

Facility Name

City

Novosibirsk

ZIP/Postal Code

630047

Country

Russian Federation

Facility Name

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

City

Saratov

ZIP/Postal Code

410002

Country

Russian Federation

Facility Name

City

Stavropol

ZIP/Postal Code

355017

Country

Russian Federation

Facility Name

City

Voronezh

ZIP/Postal Code

394066

Country

Russian Federation

Facility Name

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

City

Bratislava

ZIP/Postal Code

84231

Country

Slovakia

Facility Name

City

Dunajska Streda

ZIP/Postal Code

929 01

Country

Slovakia

Facility Name

City

Piestany

ZIP/Postal Code

921 12

Country

Slovakia

Facility Name

City

Benoni

ZIP/Postal Code

1500

Country

South Africa

Facility Name

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

City

Breyten

ZIP/Postal Code

2330

Country

South Africa

Facility Name

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

City

Durban

ZIP/Postal Code

4092

Country

South Africa

Facility Name

City

Limpopo

ZIP/Postal Code

0380

Country

South Africa

Facility Name

City

Pretoria

ZIP/Postal Code

0184

Country

South Africa

Facility Name

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

City

Stellenbosch

ZIP/Postal Code

7600

Country

South Africa

Facility Name

City

Barcelona

ZIP/Postal Code

08034

Country

Spain

Facility Name

City

Bilboa

ZIP/Postal Code

48013

Country

Spain

Facility Name

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

City

San Sebastian

ZIP/Postal Code

20014

Country

Spain

Facility Name

City

Colombo

Country

Sri Lanka

Facility Name

City

Galle

Country

Sri Lanka

Facility Name

City

Kalubowila

Country

Sri Lanka

Facility Name

City

Nugegoda

Country

Sri Lanka

Facility Name

City

Keelung

ZIP/Postal Code

204

Country

Taiwan

Facility Name

City

Kuei Shan Hsiang

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

City

Niao Sung Hsiang

ZIP/Postal Code

833

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

City

Dnipropetrovsk

ZIP/Postal Code

49008

Country

Ukraine

Facility Name

City

Donetsk

ZIP/Postal Code

83114

Country

Ukraine

Facility Name

City

Kharkiv

ZIP/Postal Code

61178

Country

Ukraine

Facility Name

City

Kiev

ZIP/Postal Code

04114

Country

Ukraine

Facility Name

City

Kyiv

ZIP/Postal Code

03151

Country

Ukraine

Facility Name

City

Odesa

ZIP/Postal Code

65026

Country

Ukraine

Facility Name

City

Poltava

ZIP/Postal Code

36038

Country

Ukraine

Facility Name

City

Simferopol

ZIP/Postal Code

95017

Country

Ukraine

Facility Name

City

Vinnitsa

ZIP/Postal Code

21000

Country

Ukraine

Facility Name

City

Vinnytsya

ZIP/Postal Code

21018

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

An Open Label Study for Participants With Rheumatoid Arthritis

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