Back to results

Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA) (CONCERTO)

Primary Purpose

Early Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

adalimumab

methotrexate

About this trial

This is an interventional treatment trial for Early Rheumatoid Arthritis focused on measuring Arthritis, Erosion, Humira, Adalimumab, Injection, Rheumatoid, Methotrexate

Eligibility Criteria

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

Inclusion Criteria:

Male and female subjects at least 18 years of age
Subject has a diagnosis of Rheumatoid Arthritis (RA) as defined by either the 1987-revised American College of Rheumatology (ACR) classification criteria or the new ACR/ European League Against Rheumatism (EULAR) diagnostic criteria for RA 2010 and has a disease duration of less than 1 year from diagnosis by a licensed health care provider
Subject must meet the following criteria:
1. Disease Activity Score of C-reactive Protein (DAS28[CRP]) ≥ 3.2 (at the Baseline visit only)
2. At least 6 swollen joints out of 66 assessed (at the Screening and Baseline visits)
3. At least 8 tender joints out of 68 assessed (at the Screening and Baseline visits)
4. C-reactive protein (CRP) ≥ 1.5 mg/dL (at the Screening visit only), or erythrocyte sedimentation rate (ESR) ≥ 28 mm/1h (at the Screening and Baseline visits)
5. Fulfill at least one of the following three criteria: Rheumatoid Factor (RF) positive, have at least 1 bony erosion, anti-cyclic citrullinated peptide (anti-CCP) antibody positive
Subject is judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (CXR), and a 12-lead electrocardiogram (ECG) performed during Screening

Exclusion Criteria:

Subject has previous exposure to any systemic biologic therapy including adalimumab
Subject has been previously treated with greater than 1 disease modifying antirheumatic drugs (DMARDs) or with methotrexate (MTX)
Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study)
Subject has chronic arthritis diagnosed before age 17 years
History of invasive infection (e.g., listeriosis and histoplasmosis), chronic or active Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB)
Hepatitis B virus: hepatitis B surface antigen (HBs Ag) positive (+) or detected sensitivity on the hepatitis B virus DNA (HBV DNA) polymerase chain reaction (PCR) qualitative test
Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline Visit or oral anti-infectives within 14 days prior to the Baseline visit
Female subject who is pregnant or breast-feeding or considering becoming pregnant

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

ADA + 2.5 mg MTX

ADA + 5 mg MTX

ADA + 10 mg MTX

ADA + 20 mg MTX

Arm Description

2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks

5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks

10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks

MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) Low Disease Activity at Week 26

Percentage of participants achieving low disease activity as defined by a clinical response (DAS28[CRP] < 3.2). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

Secondary Outcome Measures

Percentage of Participants With DAS28(CRP) Remission at Week 26

Disease remission was defined as a disease activity score, based on CRP, for 28 joints that was < 2.6 (DAS28[CRP] < 2.6). The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10.

Percentage of Participants With American College of Rheumatology (ACR) 20 Criteria Response at Week 26

Response, as defined by ACR 20 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Disability Index of the Health Assessment Questionnaire Acute phase reactant value (C-reactive protein).

Percentage of Participants With American College of Rheumatology (ACR) 50 Criteria Response at Week 26

Response, as defined by ACR 50 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Disability Index of the Health Assessment Questionnaire Acute phase reactant value (C-reactive protein).

Percentage of Participants With American College of Rheumatology (ACR) 70 Criteria Response at Week 26

Response, as defined by ACR 70 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Disability Index of the Health Assessment Questionnaire Acute phase reactant value (C-reactive protein).

Percentage of Participants With American College of Rheumatology (ACR) 90 Criteria Response at Week 26

Response, as defined by ACR 90 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Disability Index of the Health Assessment Questionnaire Acute phase reactant value (C-reactive protein).

Percentage of Participants With American College of Rheumatology (ACR) 100 Criteria Response at Week 26

Response, as defined by ACR 100 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 100% improvement in tender joint count; ≥ 100% improvement in swollen joint count; and ≥ 100% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity Patient global assessment of disease activity Patient assessment of pain Disability Index of the Health Assessment Questionnaire Acute phase reactant value (C-reactive protein).

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 26

The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline in the overall score indicates improvement.

Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ -0.22 at Week 26

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is a change from Baseline of ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline in the overall score indicates improvement.

Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26

The modified Total Sharp Score (mTSS) is a measure of change in joint health from digitized images of radiographs of hands and feet. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

Percentage of Participants With No Radiographic Progression at Week 26

"No radiographic progression" was defined as a change from Baseline in modified Total Sharp Score (mTSS) at Week 26 of ≤ 0.5. mTSS is a measure of change in joint health from digitized images of radiographs of hands and feet. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 26

SDAI is a measure of disease activity derived as follows: SDAI = SJC28 + TJC28 + GH (cm) + PhGA (cm) + CRP (mg/dL), where TJC28 and SJC28 represent total tender joint count and total swollen joint count, respectively, based on 28 joints (including the left and right side of the body), GH = Patient's Global Assessment of Disease Activity, and PhGA = Physician's Global Assessment of Disease Activity (both measured on a visual analogue scale with a range of 0 [none] to 10 [severe]), and CRP is C-reactive protein measured in mg/dL. SDAI total score = 0 to 86. SDAI ≤ 3.3 indicates disease remission, > 3.4 to 11 = low disease activity, > 11 to 26 = moderate disease activity, and > 26 = high disease activity.

Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 26

CDAI is a measure of disease activity derived as follows: CDAI = SJC28 + TJC28 + GH (cm) + PhGA (cm) where TJC28 and SJC28 represent total tender joint count and total swollen joint count, respectively, based on 28 joints (including the left and right side of the body), GH = Patient's Global Assessment of Disease Activity, and PhGA = Physician's Global Assessment of Disease Activity (both measured on a visual analogue scale with a range of 0 [none] to 10 [severe]). CDAI total score = 0 to 76. CDAI ≤ 2.8 indicates disease remission, > 2.8 to 10 = low disease activity, > 10 to 22 = moderate disease activity, and > 22 = high disease activity.

Full Information

NCT ID

NCT01185301

First Posted

August 18, 2010

Last Updated

September 11, 2013

Sponsor

AbbVie (prior sponsor, Abbott)

1. Study Identification

Unique Protocol Identification Number

NCT01185301

Brief Title

Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)

Acronym

CONCERTO

Official Title

A Double-Blind, Randomized, Parallel-Arm, Multicenter Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy With Adalimumab in Subjects With Early Rheumatoid Arthritis (CONCERTO)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the effects of different doses of methotrexate (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).

6. Conditions and Keywords

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

Early Rheumatoid Arthritis

Keywords

Arthritis, Erosion, Humira, Adalimumab, Injection, Rheumatoid, Methotrexate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

395 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ADA + 2.5 mg MTX

Arm Type

Active Comparator

Arm Description

2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks

Arm Title

ADA + 5 mg MTX

Arm Type

Active Comparator

Arm Description

5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks

Arm Title

ADA + 10 mg MTX

Arm Type

Active Comparator

Arm Description

10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks

Arm Title

ADA + 20 mg MTX

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

adalimumab

Other Intervention Name(s)

Humira

Intervention Description

Pre-filled syringe every other week

Intervention Type

Drug

Intervention Name(s)

methotrexate

Intervention Description

weekly oral capsule dosing

Primary Outcome Measure Information:

Title

Percentage of Participants With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) Low Disease Activity at Week 26

Description

Time Frame

Week 26

Secondary Outcome Measure Information:

Title

Percentage of Participants With DAS28(CRP) Remission at Week 26

Description

Time Frame

Week 26

Title

Percentage of Participants With American College of Rheumatology (ACR) 20 Criteria Response at Week 26

Description

Time Frame

Baseline, Week 26

Title

Percentage of Participants With American College of Rheumatology (ACR) 50 Criteria Response at Week 26

Description

Time Frame

Baseline, Week 26

Title

Percentage of Participants With American College of Rheumatology (ACR) 70 Criteria Response at Week 26

Description

Time Frame

Baseline, Week 26

Title

Percentage of Participants With American College of Rheumatology (ACR) 90 Criteria Response at Week 26

Description

Time Frame

Baseline, Week 26

Title

Percentage of Participants With American College of Rheumatology (ACR) 100 Criteria Response at Week 26

Description

Time Frame

Baseline, Week 26

Title

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 26

Description

Time Frame

Baseline, Week 26

Title

Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ -0.22 at Week 26

Description

Time Frame

Baseline, Week 26

Title

Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26

Description

Time Frame

Baseline, Week 26

Title

Percentage of Participants With No Radiographic Progression at Week 26

Description

Time Frame

Baseline, Week 26

Title

Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 26

Description

Time Frame

Week 26

Title

Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 26

Description

Time Frame

Week 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects at least 18 years of age Subject has a diagnosis of Rheumatoid Arthritis (RA) as defined by either the 1987-revised American College of Rheumatology (ACR) classification criteria or the new ACR/ European League Against Rheumatism (EULAR) diagnostic criteria for RA 2010 and has a disease duration of less than 1 year from diagnosis by a licensed health care provider Subject must meet the following criteria: Disease Activity Score of C-reactive Protein (DAS28[CRP]) ≥ 3.2 (at the Baseline visit only) At least 6 swollen joints out of 66 assessed (at the Screening and Baseline visits) At least 8 tender joints out of 68 assessed (at the Screening and Baseline visits) C-reactive protein (CRP) ≥ 1.5 mg/dL (at the Screening visit only), or erythrocyte sedimentation rate (ESR) ≥ 28 mm/1h (at the Screening and Baseline visits) Fulfill at least one of the following three criteria: Rheumatoid Factor (RF) positive, have at least 1 bony erosion, anti-cyclic citrullinated peptide (anti-CCP) antibody positive Subject is judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (CXR), and a 12-lead electrocardiogram (ECG) performed during Screening Exclusion Criteria: Subject has previous exposure to any systemic biologic therapy including adalimumab Subject has been previously treated with greater than 1 disease modifying antirheumatic drugs (DMARDs) or with methotrexate (MTX) Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study) Subject has chronic arthritis diagnosed before age 17 years History of invasive infection (e.g., listeriosis and histoplasmosis), chronic or active Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB) Hepatitis B virus: hepatitis B surface antigen (HBs Ag) positive (+) or detected sensitivity on the hepatitis B virus DNA (HBV DNA) polymerase chain reaction (PCR) qualitative test Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline Visit or oral anti-infectives within 14 days prior to the Baseline visit Female subject who is pregnant or breast-feeding or considering becoming pregnant

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dawn Carlson, MD

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 38973

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Site Reference ID/Investigator# 41962

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85202

Country

United States

Facility Name

Site Reference ID/Investigator# 39260

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85031

Country

United States

Facility Name

Site Reference ID/Investigator# 45323

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Site Reference ID/Investigator# 38912

City

Hemet

State/Province

California

ZIP/Postal Code

92543

Country

United States

Facility Name

Site Reference ID/Investigator# 39673

City

Victorville

State/Province

California

ZIP/Postal Code

92395

Country

United States

Facility Name

Site Reference ID/Investigator# 38909

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Site Reference ID/Investigator# 40422

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

Site Reference ID/Investigator# 38910

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Site Reference ID/Investigator# 44284

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30312

Country

United States

Facility Name

Site Reference ID/Investigator# 38907

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

Site Reference ID/Investigator# 38972

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30045

Country

United States

Facility Name

Site Reference ID/Investigator# 39670

City

Rock Island

State/Province

Illinois

ZIP/Postal Code

61201

Country

United States

Facility Name

Site Reference ID/Investigator# 42282

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Site Reference ID/Investigator# 38911

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67203

Country

United States

Facility Name

Site Reference ID/Investigator# 39672

City

Covington

State/Province

Louisiana

ZIP/Postal Code

70433

Country

United States

Facility Name

Site Reference ID/Investigator# 42204

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Site Reference ID/Investigator# 40651

City

Clifton

State/Province

New Jersey

ZIP/Postal Code

07012

Country

United States

Facility Name

Site Reference ID/Investigator# 41422

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

Site Reference ID/Investigator# 41424

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Site Reference ID/Investigator# 40463

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Site Reference ID/Investigator# 42202

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Site Reference ID/Investigator# 44282

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73069

Country

United States

Facility Name

Site Reference ID/Investigator# 41423

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Site Reference ID/Investigator# 38971

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Site Reference ID/Investigator# 39666

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Site Reference ID/Investigator# 39643

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Site Reference ID/Investigator# 45325

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Site Reference ID/Investigator# 52042

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Site Reference ID/Investigator# 40602

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

Site Reference ID/Investigator# 44924

City

Buenos Aires

ZIP/Postal Code

C1055AAF

Country

Argentina

Facility Name

Site Reference ID/Investigator# 44926

City

Buenos Aires

ZIP/Postal Code

C1425DTG

Country

Argentina

Facility Name

Site Reference ID/Investigator# 44925

City

Rosario, Santa Fe

ZIP/Postal Code

S2000PBJ

Country

Argentina

Facility Name

Site Reference ID/Investigator# 47302

City

San Juan

ZIP/Postal Code

J5402DIL

Country

Argentina

Facility Name

Site Reference ID/Investigator# 44928

City

Graz

ZIP/Postal Code

80360

Country

Austria

Facility Name

Site Reference ID/Investigator# 44930

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Site Reference ID/Investigator# 44927

City

Vienna

ZIP/Postal Code

1100

Country

Austria

Facility Name

Site Reference ID/Investigator# 44934

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Site Reference ID/Investigator# 44935

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Site Reference ID/Investigator# 44933

City

Gilly

ZIP/Postal Code

6060

Country

Belgium

Facility Name

Site Reference ID/Investigator# 44932

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Site Reference ID/Investigator# 43783

City

Edmonton

ZIP/Postal Code

T5M 0H4

Country

Canada

Facility Name

Site Reference ID/Investigator# 43782

City

Winnipeg

ZIP/Postal Code

R3A 1M3

Country

Canada

Facility Name

Site Reference ID/Investigator# 44937

City

Brno

ZIP/Postal Code

63800

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 48962

City

Ceske Budejovice

ZIP/Postal Code

37021

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 44939

City

Ostrava

ZIP/Postal Code

72200

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 44936

City

Prague 2

ZIP/Postal Code

128 50

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 44938

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 48963

City

Zlin

ZIP/Postal Code

76001

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 44945

City

Berlin-Buch

ZIP/Postal Code

13125

Country

Germany

Facility Name

Site Reference ID/Investigator# 44941

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Site Reference ID/Investigator# 44942

City

Munich

ZIP/Postal Code

80336

Country

Germany

Facility Name

Site Reference ID/Investigator# 44944

City

Ratingen

ZIP/Postal Code

40882

Country

Germany

Facility Name

Site Reference ID/Investigator# 44943

City

Zerbst

ZIP/Postal Code

39261

Country

Germany

Facility Name

Site Reference ID/Investigator# 44946

City

Bydgoszcz

ZIP/Postal Code

85168

Country

Poland

Facility Name

Site Reference ID/Investigator# 44982

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

Site Reference ID/Investigator# 46584

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Site Reference ID/Investigator# 44984

City

Warsaw

ZIP/Postal Code

02-118

Country

Poland

Facility Name

Site Reference ID/Investigator# 44983

City

Warsaw

ZIP/Postal Code

02-256

Country

Poland

Facility Name

Site Reference ID/Investigator# 38975

City

Caguas

ZIP/Postal Code

00725

Country

Puerto Rico

Facility Name

Site Reference ID/Investigator# 40122

City

San Juan

ZIP/Postal Code

00906-6312

Country

Puerto Rico

Facility Name

Site Reference ID/Investigator# 39693

City

San Juan

ZIP/Postal Code

00936-5067

Country

Puerto Rico

Facility Name

Site Reference ID/Investigator# 38916

City

San Juan

ZIP/Postal Code

00936-8344

Country

Puerto Rico

Facility Name

Site Reference ID/Investigator# 39692

City

Vega Baja

ZIP/Postal Code

00693

Country

Puerto Rico

Facility Name

Site Reference ID/Investigator# 44947

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Site Reference ID/Investigator# 44987

City

Elche (Alicante)

ZIP/Postal Code

03203

Country

Spain

Facility Name

Site Reference ID/Investigator# 44948

City

Oviedo (Asturias)

ZIP/Postal Code

33006

Country

Spain

Facility Name

Site Reference ID/Investigator# 47782

City

Valencia

ZIP/Postal Code

46026

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

29402521

Citation

Goss SL, Klein CE, Jin Z, Locke CS, Rodila RC, Kupper H, Burmester GR, Awni WM. Methotrexate Dose in Patients With Early Rheumatoid Arthritis Impacts Methotrexate Polyglutamate Pharmacokinetics, Adalimumab Pharmacokinetics, and Efficacy: Pharmacokinetic and Exposure-response Analysis of the CONCERTO Trial. Clin Ther. 2018 Feb;40(2):309-319. doi: 10.1016/j.clinthera.2018.01.002.

Results Reference

derived

PubMed Identifier

28955494

Citation

Burmester GR, Kaeley GS, Kavanaugh AF, Gabay C, MacCarter DK, Nash P, Takeuchi T, Goss SL, Rodila R, Chen K, Kupper H, Kalabic J. Treatment efficacy and methotrexate-related toxicity in patients with rheumatoid arthritis receiving methotrexate in combination with adalimumab. RMD Open. 2017 Sep 17;3(2):e000465. doi: 10.1136/rmdopen-2017-000465. eCollection 2017.

Results Reference

derived

PubMed Identifier

27338778

Citation

Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

Results Reference

derived

Links:

URL

http://www.rxabbvie.com

Description

Related Info

Learn more about this trial

Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)

We'll reach out to this number within 24 hrs

Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA) (CONCERTO)

Early Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial