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Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Adalimumab

Placebo

Adalimumab

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: Age 18 or older and in good health (Investigator discretion) with a recent stable medical history Met American College of Rheumatology (ACR) criteria for diagnosis of active rheumatoid arthritis (RA) and had at both screening and baseline visits >=6 swollen joints and >=9 tender joints, despite a minimum of 3-months treatment with methotrexate (MTX). (Distal interphalangeal joints [DIPs] were not to be included in joint count for inclusion. The screening and baseline visits could be 3 to 28 days apart for patients not previously receiving disease-modifying anti-rheumatic drugs [DMARDs] other than MTX or 4 to 6 weeks for patients requiring a DMARD washout period.) Insufficient efficacy with MTX 12.5 to 25 mg per week (10 mg per week if MTX intolerant). If patient on a second-line treatment (DMARD) other than MTX, he/she had to discontinue it for at least 28 days before the baseline visit (the washout period). Treatment with oral folic acid 1-3 mg/day or, if appropriate, up to 10 mg leucovorin per week. Both rheumatoid factor positivity and a C-reactive protein value >=1 mg/dL, or at least one joint erosion on X-ray. Exclusion Criteria: Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study. Female subject who was pregnant or breast-feeding or considering becoming pregnant. Preceding treatment with any tumor necrosis factor (TNF) antagonist, including adalimumab. Prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide. Intra-articular, intramuscular, or intravenous administration of corticosteroids within 4 weeks prior to the screening visit. Subject was wheelchair bound or bedridden.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

DB adalimumab 20 mg ew

DB adalimumab 40 mg eow

DB placebo ew

DB adalimumab 20 mg ew/OL adalimumab 40 mg eow

DB adalimumab 40 mg eow/OL adalimumab 40 mg eow

DB placebo ew/OL adalimumab 40 mg eow

Arm Description

Subjects received 20 mg adalimumab subcutaneously (SC) once weekly (ew) and concomitant methotrexate (MTX) during the double-blind (DB) phase.

Subjects received 40 mg adalimumab subcutaneously (SC) every other week (eow) and concomitant methotrexate (MTX) during the double-blind (DB) phase. Subjects received placebo injections SC and concomitant MTX on the alternate weeks during the DB phase.

Subjects received placebo subcutaneously (SC) once weekly (ew) and concomitant methotrexate (MTX) during the double-blind (DB) phase.

Subjects received adalimumab 20 mg subcutaneously (SC) once weekly (ew) during the double-blind (DB) phase, then adalimumab 40 mg SC every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).

Subjects received adalimumab 40 mg subcutaneously (SC) every other week (eow) with placebo on alternate weeks during the double-blind (DB) phase, then adalimumab 40 mg SC eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).

Subjects received placebo subcutaneously (SC) once weekly (ew) during the double-blind phase, then adalimumab 40 mg SC every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).

Outcomes

Primary Outcome Measures

Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24

Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.

Change From Baseline in Modified Total Sharp X-ray Score at Week 52

Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 52. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.

Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52

Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.

Secondary Outcome Measures

Number of Participants Meeting ACR20 Response Criteria at Week 52

Change From Baseline in Modified Total Sharp X-ray Score at Week 24

Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 24. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.

Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24

Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24

Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Responders had a >= 0.22-unit decrease (improvement) in HAQ scores from baseline to Week 12 or 24.

Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24

Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment

Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.

Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point

Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point

Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.

Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point

Estimated Yearly Progression of Rheumatoid Arthritis

Estimated yearly progression was defined as modified total Sharp x-ray score at baseline divided by duration of rheumatoid arthritis disease at baseline. Actual progression during the study was defined as modified total Sharp x-ray score at Week 52 minus modified total Sharp x-ray score at baseline divided by the duration of the study. The range of scores for the modified total Sharp x-ray score was 0 (normal) to 398 (maximal disease).

Full Information

NCT ID

NCT00195702

First Posted

September 13, 2005

Last Updated

August 23, 2011

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00195702

Brief Title

Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Rheumatoid Arthritis Patients Currently Receiving Treatment With Methotrexate

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

February 2000 (undefined)

Primary Completion Date

September 2002 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab (during open-label extension phase) in patients with persistently active rheumatoid arthritis who were receiving concurrent methotrexate therapy.

Detailed Description

This was a 10-year study which had an initial 52-week, double-blind, placebo-controlled phase followed by an open-label extension phase up to 9 years in duration. Data were analyzed for the double-blind phase using all patients who were randomized and received at least one dose of study drug through Week 52 and for all patients who received at least one dose of adalimumab during the 10-year study (the Intent-to-Treat [ITT] population).

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

ParticipantInvestigator

Allocation

Randomized

Enrollment

619 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DB adalimumab 20 mg ew

Arm Type

Experimental

Arm Description

Subjects received 20 mg adalimumab subcutaneously (SC) once weekly (ew) and concomitant methotrexate (MTX) during the double-blind (DB) phase.

Arm Title

DB adalimumab 40 mg eow

Arm Type

Experimental

Arm Description

Arm Title

DB placebo ew

Arm Type

Placebo Comparator

Arm Description

Subjects received placebo subcutaneously (SC) once weekly (ew) and concomitant methotrexate (MTX) during the double-blind (DB) phase.

Arm Title

DB adalimumab 20 mg ew/OL adalimumab 40 mg eow

Arm Type

Experimental

Arm Description

Arm Title

DB adalimumab 40 mg eow/OL adalimumab 40 mg eow

Arm Type

Experimental

Arm Description

Arm Title

DB placebo ew/OL adalimumab 40 mg eow

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Adalimumab

Other Intervention Name(s)

ABT-D2E7, Humira

Intervention Description

Self-administered, subcutaneous injection of 20 mg adalimumab (1.6 mL/injection) once weekly (ew) for up to 52 weeks.

Intervention Type

Biological

Intervention Name(s)

Adalimumab

Other Intervention Name(s)

ABT-D2E7, Humira

Intervention Description

Self-administered, subcutaneous injection of 40 mg adalimumab (1.6 mL/injection) every other week (eow) for up to 52 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Self-administered, subcutaneous injection of placebo (1.6 mL/injection) once weekly (ew) for up to 52 weeks.

Intervention Type

Biological

Intervention Name(s)

Adalimumab

Other Intervention Name(s)

ABT-D2E7, Humira

Intervention Description

Self-administration, subcutaneous (SC) injection of adalimumab 20 mg (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.

Intervention Type

Biological

Intervention Name(s)

Adalimumab

Other Intervention Name(s)

ABT-D2E7, Humira

Intervention Description

Self-administration, subcutaneous (SC) injection of adalimumab 40 mg (1.6 mL/injection) every other week (eow) (with a placebo 1.6 mL/injection on alternate weeks) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL injection) eow for up to Week 520.

Intervention Type

Biological

Intervention Name(s)

Adalimumab

Other Intervention Name(s)

ABT-D2E7, Humira

Intervention Description

Self-administration, subcutaneous (SC) injection of placebo solution (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.

Primary Outcome Measure Information:

Title

Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24

Description

Time Frame

Week 24

Title

Change From Baseline in Modified Total Sharp X-ray Score at Week 52

Description

Time Frame

Baseline and Week 52

Title

Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52

Description

Time Frame

Baseline and Week 52

Secondary Outcome Measure Information:

Title

Number of Participants Meeting ACR20 Response Criteria at Week 52

Description

Time Frame

Week 52

Title

Change From Baseline in Modified Total Sharp X-ray Score at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24

Description

Time Frame

Baseline and Week 24

Title

Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24

Description

Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Responders had a >= 0.22-unit decrease (improvement) in HAQ scores from baseline to Week 12 or 24.

Time Frame

Week 52

Title

Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24

Description

Time Frame

Week 52

Title

Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment

Description

Time Frame

Baseline through Week 52

Title

Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point

Description

Time Frame

Baseline through Week 52

Title

Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point

Description

Time Frame

Baseline through Week 52

Title

Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point

Description

Time Frame

Baseline through Week 52

Title

Estimated Yearly Progression of Rheumatoid Arthritis

Description

Time Frame

Baseline and Week 52

Other Pre-specified Outcome Measures:

Title

Baseline Measure: Gender - Female/Male - for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)

Description

Gender (female/male) recorded at Baseline for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.

Time Frame

Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group

Title

Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)

Description

Age recorded at Baseline, reported by category, for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.

Time Frame

Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) Group

Title

Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260

Description

Time Frame

Week 260

Title

Number of Participants Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 520

Description

Time Frame

Week 520

Title

Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260

Description

Time Frame

Week 260

Title

Number of Participants Meeting the American College of Rheumatology 50% (ACR50) Response Criteria at Week 520

Description

Time Frame

Week 520

Title

Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 260

Description

Time Frame

Week 260

Title

Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 520

Description

Time Frame

Week 520

Title

Number of Participants With a Continuous American College of Rheumatology 70% (ACR70) Response for at Least 6 Months Through Year 10

Description

Patients were responders if they had: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein.

Time Frame

Baseline through Week 520

Title

Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 260

Description

The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.

Time Frame

Week 260

Title

Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 520

Description

Time Frame

Week 520

Title

Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260

Description

Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.

Time Frame

Baseline and Week 260

Title

Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520

Description

Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.

Time Frame

Baseline and Week 520

Title

Change From Baseline in Modified Total Sharp X-ray Score at Week 416

Description

Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 416. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.

Time Frame

Baseline and Week 416

Title

Change From Baseline in Modified Total Sharp X-ray Score at Week 520

Description

Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 520. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.

Time Frame

Baseline and Week 520

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Redden, MD, PhD

Organizational Affiliation

Abbott

Official's Role

Study Director

Facility Information:

Facility Name

Site Ref # / Investigator 424

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Site Ref # / Investigator 2510

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Site Ref # / Investigator 60729

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85012

Country

United States

Facility Name

Site Ref # / Investigator 725

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85260

Country

United States

Facility Name

Site Ref # / Investigator 60736

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Site Ref # / Investigator 360

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Site Ref # / Investigator 714

City

La Jolla

State/Province

California

ZIP/Postal Code

92037-0943

Country

United States

Facility Name

Site Ref # / Investigator 469

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Site Ref # / Investigator 419

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Site Ref # / Investigator 492

City

San Jose

State/Province

California

ZIP/Postal Code

95126

Country

United States

Facility Name

Site Ref # / Investigator 60734

City

San Louis Obispo

State/Province

California

ZIP/Postal Code

93405

Country

United States

Facility Name

Site Ref # / Investigator 60739

City

Van Nuys

State/Province

California

ZIP/Postal Code

91405

Country

United States

Facility Name

Site Ref # / Investigator 712

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

Site Ref # / Investigator 710

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Site Ref # / Investigator 498

City

Dunedin

State/Province

Florida

ZIP/Postal Code

34698

Country

United States

Facility Name

Site Ref # / Investigator 499

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Site Ref # / Investigator 729

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Site Ref # / Investigator 463

City

Zephyrhills

State/Province

Florida

ZIP/Postal Code

33542

Country

United States

Facility Name

Site Ref # / Investigator 2436

City

Boise

State/Province

Idaho

ZIP/Postal Code

83704

Country

United States

Facility Name

Site Ref # / Investigator 485

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Site Ref # / Investigator 60732

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Site Ref # / Investigator 726

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Site Ref # / Investigator 2506

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Site Ref # / Investigator 732

City

South Bend

State/Province

Indiana

ZIP/Postal Code

46601

Country

United States

Facility Name

Site Ref # / Investigator 60730

City

Shawnee Mission

State/Province

Kansas

ZIP/Postal Code

66216

Country

United States

Facility Name

Site Ref # / Investigator 467

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67203

Country

United States

Facility Name

Site Ref # / Investigator 494

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67208

Country

United States

Facility Name

Site Ref # / Investigator 491

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40509

Country

United States

Facility Name

Site Ref # / Investigator 2508

City

Portland

State/Province

Maine

ZIP/Postal Code

04102

Country

United States

Facility Name

Site Ref # / Investigator 392

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21239

Country

United States

Facility Name

Site Ref # / Investigator 354

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

Site Ref # / Investigator 730

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Site Ref # / Investigator 465

City

Burlington

State/Province

Massachusetts

ZIP/Postal Code

01805

Country

United States

Facility Name

Site Ref # / Investigator 2512

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01610

Country

United States

Facility Name

Site Ref # / Investigator 471

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49506

Country

United States

Facility Name

Site Ref # / Investigator 473

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49009

Country

United States

Facility Name

Site Ref # / Investigator 731

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

Site Ref # / Investigator 502

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Site Ref # / Investigator 482

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Site Ref # / Investigator 371

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Site Ref # / Investigator 487

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Site Ref # / Investigator 353

City

Concord

State/Province

New Hampshire

ZIP/Postal Code

03301

Country

United States

Facility Name

Site Ref # / Investigator 364

City

Dover

State/Province

New Hampshire

ZIP/Postal Code

03820

Country

United States

Facility Name

Site Ref # / Investigator 60726

City

Mercerville

State/Province

New Jersey

ZIP/Postal Code

08619

Country

United States

Facility Name

Site Ref # / Investigator 358

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

Site Ref # / Investigator 483

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Site Ref # / Investigator 512

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

Site Ref # / Investigator 340

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Site Ref # / Investigator 461

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

Site Ref # / Investigator 500

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

Site Ref # / Investigator 60731

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Site Ref # / Investigator 60737

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Site Ref # / Investigator 456

City

Mayfield Village

State/Province

Ohio

ZIP/Postal Code

44143

Country

United States

Facility Name

Site Ref # / Investigator 470

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Site Ref # / Investigator 60723

City

Oklahoma

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Site Ref # / Investigator 422

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

Site Ref # / Investigator 60735

City

Colmar

State/Province

Pennsylvania

ZIP/Postal Code

18915-9671

Country

United States

Facility Name

Site Ref # / Investigator 2507

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Site Ref # / Investigator 717

City

East Norriton

State/Province

Pennsylvania

ZIP/Postal Code

19401

Country

United States

Facility Name

Site Ref # / Investigator 352

City

Mechanicsburg

State/Province

Pennsylvania

ZIP/Postal Code

17055

Country

United States

Facility Name

Site Ref # / Investigator 480

City

Wexford

State/Province

Pennsylvania

ZIP/Postal Code

15090

Country

United States

Facility Name

Site Ref # / Investigator 2511

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Site Ref # / Investigator 60724

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Site Ref # / Investigator 718

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Site Ref # / Investigator 460

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Site Ref # / Investigator 462

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Site Ref # / Investigator 716

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Site Ref # / Investigator 60728

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555-0759

Country

United States

Facility Name

Site Ref # / Investigator 2509

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Site Ref # / Investigator 510

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Site Ref # / Investigator 60725

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22044

Country

United States

Facility Name

Site Ref # / Investigator 711

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219

Country

United States

Facility Name

Site Ref # / Investigator 509

City

Seattle

State/Province

Washington

ZIP/Postal Code

98166-2967

Country

United States

Facility Name

Site Ref # / Investigator 356

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Site Ref # / Investigator 464

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Site Ref # / Investigator 60738

City

Kenosha

State/Province

Wisconsin

ZIP/Postal Code

53142

Country

United States

Facility Name

Site Ref # / Investigator 475

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N1

Country

Canada

Facility Name

Site Ref # / Investigator 495

City

Penticton

State/Province

British Columbia

ZIP/Postal Code

V2A 3G8

Country

Canada

Facility Name

Site Ref # / Investigator 2496

City

Richmond

State/Province

British Columbia

ZIP/Postal Code

V7C 5L9

Country

Canada

Facility Name

Site Ref # / Investigator 2495

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3N OK6

Country

Canada

Facility Name

Site Ref # / Investigator 496

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 4K4

Country

Canada

Facility Name

Site Ref # / Investigator 444

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 3R7

Country

Canada

Facility Name

Site Ref # / Investigator 2497

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Site Ref # / Investigator 478

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5L 3L9

Country

Canada

Facility Name

Site Ref # / Investigator 421

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

Site Ref # / Investigator 363

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3Z 2Z3

Country

Canada

Facility Name

Site Ref # / Investigator 60702

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 0W8

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

31707982

Citation

Smolen J, Fleischmann R, Aletaha D, Li Y, Zhou Y, Sainsbury I, Galindo IL. Disease activity improvements with optimal discriminatory ability between treatment arms: applicability in early and established rheumatoid arthritis clinical trials. Arthritis Res Ther. 2019 Nov 10;21(1):231. doi: 10.1186/s13075-019-2005-9.

Results Reference

derived

PubMed Identifier

29018564

Citation

Keystone EC, Breedveld FC, van der Heijde D, van Vollenhoven RF, Emery P, Smolen JS, Sainsbury I, Florentinus S, Kupper H, Chen K, Kavanaugh A. Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone. RMD Open. 2017 Sep 26;3(2):e000445. doi: 10.1136/rmdopen-2017-000445. 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

PubMed Identifier

25139667

Citation

Emery P, Kavanaugh A, Bao Y, Ganguli A, Mulani P. Comprehensive disease control (CDC): what does achieving CDC mean for patients with rheumatoid arthritis? Ann Rheum Dis. 2015 Dec;74(12):2165-74. doi: 10.1136/annrheumdis-2014-205302. Epub 2014 Aug 19.

Results Reference

derived

PubMed Identifier

25073879

Citation

Landewe R, Ostergaard M, Keystone EC, Florentinus S, Liu S, van der Heijde D. Analysis of integrated radiographic data from two long-term, open-label extension studies of adalimumab for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015 Feb;67(2):180-6. doi: 10.1002/acr.22426.

Results Reference

derived

PubMed Identifier

23818718

Citation

Keystone EC, van der Heijde D, Kavanaugh A, Kupper H, Liu S, Guerette B, Mozaffarian N. Clinical, functional, and radiographic benefits of longterm adalimumab plus methotrexate: final 10-year data in longstanding rheumatoid arthritis. J Rheumatol. 2013 Sep;40(9):1487-97. doi: 10.3899/jrheum.120964. Epub 2013 Jul 1.

Results Reference

derived

PubMed Identifier

21285171

Citation

Keystone EC, Kavanaugh A, Weinblatt ME, Patra K, Pangan AL. Clinical consequences of delayed addition of adalimumab to methotrexate therapy over 5 years in patients with rheumatoid arthritis. J Rheumatol. 2011 May;38(5):855-62. doi: 10.3899/jrheum.100752. Epub 2011 Feb 1.

Results Reference

derived

Learn more about this trial

Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.

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Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

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