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Remission and Joint Damage Progression in Early Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Abatacept

placebo

methotrexate

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring abatacept, methotrexate, erosive RA

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of rheumatoid arthritis (RA) <=2 years; MTX naive or <=10 mg/wk for <=3 weeks. No dose within 3 months prior to informed consent. C-Reactive Protein (CRP) >= 4.5 mg/L (after amendment) Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive Tender joints >=12 and swollen joints >=10 Exclusion Criteria: Women and men who are not willing to use birth control Diagnosed with other rheumatic disease History of cancer within 5 years Active tuberculosis Treatment with another investigation drug within 28 days Active bacterial or viral infection

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ABA + MTX

Placebo (PLA) + MTX

Arm Description

abatacept 10 mg/kg intravenous (IV) + methotrexate

placebo IV + methotrexate

Outcomes

Primary Outcome Measures

Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12

Number of participants who achieved remission at Month 12 of treatment, as defined by a Disease Activity Score (DAS) 28-CRP score of <2.6. DAS 28-CRP is a continuous measure, a composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, CRP (in mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 (best) to 10 (worst), indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1 = high disease activity; <=3.2 = low disease activity; <2.6 = remission.

Mean Change From Baseline in Radiographic Total Score to Month 12

To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.

Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs During the Open-Label Period

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

Number of Participants With Serious Adverse Events Reported During the Open-Label Period

SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

Number of Participants With SAEs With an Outcome of Death During the Open-label Period

Any untoward medical occurrence (SAE) that resulted in death

Incidence Rates of Autoimmune Disorders in ABA-Treated Participants

The incidence rates of autoimmune disorders are defined as the (number of patients experiencing the event/exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.

Incidence Rates of Infections and Infestations of Adverse Events in ABA-Treated Participants

The incidence rates of infections and infestations are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.

Incidence Rates of Malignant Neoplasm Adverse Events in ABA-Treated Participants

The incidence rates of malignant neoplasms are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.

Number of Participants With a Serious Acute-Infusional AE of Anaphylactic Shock During Open-Label Period

There were 107 Prespecified, acute-infusional SAEs (occurring within 1 hour after the start of study drug infusion) pre-specified in the protocol; anaphylactic shock was the only one occuring in this study.

Number of Participants With Select Blood Chemistry Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period

Number of subjects with high liver function and kinedy tests: alkaline phosphatase (ALP) >2x upper limit of normal (ULN) or if pretreatment (PRE-RX) >ULN then >3x PRE-RX; aspartate aminotransferase (AST) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; alanine aminotransferase (ALT) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; g-glutamyl transferase (GGT)>2x ULN or if PRE-RX >ULN then >3x PRE-RX; total bilirubin >2x ULN or if PRE-RX >ULN then >4x PRE-RX; blood urea nitrogen >2x PRE-RX; creatinine >1.5x PRE-RX.

Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period

Marked abnormalities in hemoglobin >3 g/dL decrease from PRE-RX; hematocrit <0.75x PRE-RX; erythrocytes <0.75x PRE-RX; platelet count <0.67x lower limit of normal (LLN) or >1.5x ULN or if PRE-RX <LLN then <0.5x PRE-RX and <100,000/mm3; leukocytes <0.75x LLN or >1.25x ULN or if PRE-RX <LLN then <0.8x PRE-RX or >ULN if PRE-RX >ULN then >1.2x PRE-RX or <LLN; neutrophils if value <1.00 x10^3 c/uL; lymphocytes if value <.750 x10^3 c/uL or if value >7.50 x10^3 c/uL; monocytes if value >2000/MM3; basophils if value >400/mm3; eosinophils if value >.750 x10^3 c/uL

Secondary Outcome Measures

Number of Participants With American College of Rheumatology (ACR) 50 Response at Month 12

ACR 50 response was defined as a 50% improvement from baseline to Month 12 in tender and swollen joint counts and 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function), and 1 acute phase reactant value [ie, CRP].

Number of Participants With Major Clinical Response (MCR) at Month 12

MCR was defined as 6 months of consecutive ACR 70 response at Month 12. ACR 70, the American College of Rheumatology (ACR) definition of 70% improvement was based on a 70% improvement (compared to baseline values) in tender and swollen joint counts and 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function, and 1 acute phase reactant value [ie, CRP]).

Adjusted Mean Change From Baseline in DAS-28-CRP Score to Month 12

DAS 28-CRP is a continuous variable that is a composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, CRP in milligrams/Liter (mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 to 10, indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1=high disease activity; <3.2=low disease activity; <2.6=remission. Change from Baseline=Post-baseline - Baseline value; Adjusted for baseline value.

Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 12

Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.

Adjusted Mean Change in Short Form 36 (SF-36) From Baseline to Month 12

The SF-36 covers 8 health dimensions: 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from 0 to 100, with a higher score indicating better quality of life. Two summary scores (physical and mental component summaries) were produced taking a weighted linear combination of the 8 individual subscales. Change from Baseline=Post-baseline - Baseline value; adjusted for baseline value.

Mean Change From Baseline in Radiographic Erosion and Joint Space Narrowing (JSN) Scores to Month 12

To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). The joint space narrowing score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value

Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses in the Double-blind Period as Analyzed by Enzyme-linked-immunosorbent Serologic Assay (ELISA)

Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).

Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses During the Open-Label Period (From Month 12 to Month 24) as Analyzed by ELISA

Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 24

Mean Change From Baseline in Radiographic Total, Erosion and JSN Scores to Month 24

To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Postbaseline - baseline value.

Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) From Baseline at Month 24

Participants with no radiographic progression (defined as change in score <=0 or <=0.5), from baseline to Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.

Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) at Month 24 in Participants Without Progression at Month 12

Participants with no radiographic progression ((defined as change in score <=0 or <=0.5), sustained from Month 12 and Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.

Mean Difference Observed in Change From Baseline to Month 12 and Between Month 12 and Month 24 in Radiographic Scores (Total Score)

Mean difference observed in change from baseline to Month 12 and between Month 12 and Month 24 in radiographic scores (Total Score). To assess joint damage, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Reported During the Double-blind Period

Number of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During the Double-blind Period

Number of participants with laboratory values (hematology, liver and kidney functions, electrolytes, glucose tests, protein tests, metabolite tests, and urine chemistry tests) considered markedly abnormal according to prespecified protocol criteria

Full Information

NCT ID

NCT00122382

First Posted

July 19, 2005

Last Updated

November 3, 2010

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00122382

Brief Title

Remission and Joint Damage Progression in Early Rheumatoid Arthritis

Official Title

A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

6. Conditions and Keywords

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

Rheumatoid Arthritis

Keywords

abatacept, methotrexate, erosive RA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1052 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABA + MTX

Arm Type

Active Comparator

Arm Description

abatacept 10 mg/kg intravenous (IV) + methotrexate

Arm Title

Placebo (PLA) + MTX

Arm Type

Active Comparator

Arm Description

placebo IV + methotrexate

Intervention Type

Drug

Intervention Name(s)

Abatacept

Intervention Description

abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months

Intervention Type

Drug

Intervention Name(s)

methotrexate

Intervention Description

Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24

Primary Outcome Measure Information:

Title

Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12

Description

Time Frame

Month 12

Title

Mean Change From Baseline in Radiographic Total Score to Month 12

Description

Time Frame

Baseline, Month 12

Title

Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs During the Open-Label Period

Description

Time Frame

Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.

Title

Number of Participants With Serious Adverse Events Reported During the Open-Label Period

Description

Time Frame

Title

Number of Participants With SAEs With an Outcome of Death During the Open-label Period

Description

Any untoward medical occurrence (SAE) that resulted in death

Time Frame

Title

Incidence Rates of Autoimmune Disorders in ABA-Treated Participants

Description

Time Frame

Double Blind Period (+56 days post last dose in double-blind period or start of open-label period, whichever came first). Open-label period (56 days post last dose in the open-label period or start of maintenance sub-study, whichever came first).

Title

Incidence Rates of Infections and Infestations of Adverse Events in ABA-Treated Participants

Description

Time Frame

Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).

Title

Incidence Rates of Malignant Neoplasm Adverse Events in ABA-Treated Participants

Description

Time Frame

Title

Number of Participants With a Serious Acute-Infusional AE of Anaphylactic Shock During Open-Label Period

Description

Time Frame

Open-Label Period (Month 12 to Month 24)

Title

Number of Participants With Select Blood Chemistry Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period

Description

Time Frame

Title

Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period

Description

Time Frame

Continuously from start of open-label period up to 56 days post the last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.

Secondary Outcome Measure Information:

Title

Number of Participants With American College of Rheumatology (ACR) 50 Response at Month 12

Description

Time Frame

Month 12

Title

Number of Participants With Major Clinical Response (MCR) at Month 12

Description

Time Frame

Month 12

Title

Adjusted Mean Change From Baseline in DAS-28-CRP Score to Month 12

Description

Time Frame

Baseline, Month 12

Title

Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 12

Description

Time Frame

Month 12

Title

Adjusted Mean Change in Short Form 36 (SF-36) From Baseline to Month 12

Description

Time Frame

Baseline, Month 12

Title

Mean Change From Baseline in Radiographic Erosion and Joint Space Narrowing (JSN) Scores to Month 12

Description

Time Frame

Baseline, Month 12

Title

Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses in the Double-blind Period as Analyzed by Enzyme-linked-immunosorbent Serologic Assay (ELISA)

Description

Time Frame

includes data up to approximately 85 days past the last dose of the double-blind period or start of the open-label period, whichever occurred first.

Title

Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses During the Open-Label Period (From Month 12 to Month 24) as Analyzed by ELISA

Description

Time Frame

Includes open-label data up to approximately 85 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.

Title

Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 24

Description

Time Frame

Baseline, Month 24

Title

Mean Change From Baseline in Radiographic Total, Erosion and JSN Scores to Month 24

Description

Time Frame

Baseline, Month 24

Title

Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) From Baseline at Month 24

Description

Time Frame

Baseline, Month 24

Title

Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) at Month 24 in Participants Without Progression at Month 12

Description

Time Frame

Month 12, Month 24

Title

Mean Difference Observed in Change From Baseline to Month 12 and Between Month 12 and Month 24 in Radiographic Scores (Total Score)

Description

Time Frame

Baseline, Month 12, Month 24

Title

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Reported During the Double-blind Period

Description

Time Frame

Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.

Title

Number of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During the Double-blind Period

Description

Time Frame

Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.

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

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Rheumatology Associates Of North Alabama

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Talbert Medical Group

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92646

Country

United States

Facility Name

Arthritis Assoc And Osteo Ctr Of Col Sprgs

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80910

Country

United States

Facility Name

New England Research Associates, Llc

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

Diagnostic Rheumatology And Research

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46227

Country

United States

Facility Name

Osteoporosis And Clinical Trials Center

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

Malamet & Klein, Md, Pa

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

Facility Name

Arthritis Center Of Nebraska

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Regional Rheumatology Associates

City

Binghamton

State/Province

New York

ZIP/Postal Code

13905

Country

United States

Facility Name

Carolina Bone & Joint

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Physicians East, Pa

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Carolina Pharmaceutical Research

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28625

Country

United States

Facility Name

Lion Research

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73071

Country

United States

Facility Name

Health Research Of Oklahoma

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Lynn Health Sciences Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Altoona Center For Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Low Country Research Center

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Walter F Chase Md Pa

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Arthritis Clinic Of Northern Virginia, P.C.

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22205

Country

United States

Facility Name

Local Institution

City

Malvern

State/Province

Victoria

ZIP/Postal Code

3144

Country

Australia

Facility Name

Local Institution

City

Shenton Park

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

Local Institution

City

Antwerpen

ZIP/Postal Code

2020

Country

Belgium

Facility Name

Local Institution

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Local Institution

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Local Institution

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Local Institution

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Local Institution

City

Goiania

State/Province

Goias

ZIP/Postal Code

74043

Country

Brazil

Facility Name

Local Institution

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80060

Country

Brazil

Facility Name

Local Institution

City

Rio De Janeiro - Rj

State/Province

Rio De Janeiro

ZIP/Postal Code

20551

Country

Brazil

Facility Name

Local Institution

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

91610

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

04039

Country

Brazil

Facility Name

Local Institution

City

Sao Paulo

ZIP/Postal Code

04230

Country

Brazil

Facility Name

Local Institution

City

St. John'S

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3E1

Country

Canada

Facility Name

Local Institution

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2M 5N6

Country

Canada

Facility Name

Local Institution

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X5

Country

Canada

Facility Name

Local Institution

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 1S6

Country

Canada

Facility Name

Local Institution

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Local Institution

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 0W8

Country

Canada

Facility Name

Local Institution

City

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

Local Institution

City

Prague 2

ZIP/Postal Code

128 50

Country

Czech Republic

Facility Name

Local Institution

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Local Institution

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Local Institution

City

Nice Cedex 03

ZIP/Postal Code

06202

Country

France

Facility Name

Local Institution

City

Strasbourg Cedex

ZIP/Postal Code

67098

Country

France

Facility Name

Local Institution

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Local Institution

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Local Institution

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Local Institution

City

Leipzig

ZIP/Postal Code

04229

Country

Germany

Facility Name

Local Institution

City

Jesi(Ancona)

ZIP/Postal Code

60055

Country

Italy

Facility Name

Local Institution

City

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

Local Institution

City

Anyang

ZIP/Postal Code

431-070

Country

Korea, Republic of

Facility Name

Local Institution

City

Daegu

ZIP/Postal Code

705-718

Country

Korea, Republic of

Facility Name

Local Institution

City

Daejeon

ZIP/Postal Code

302-799

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

133-792

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

137-040

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Local Institution

City

D.f.

State/Province

Distrito Federal

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Local Institution

City

Metepec

State/Province

Estado De Mexico

ZIP/Postal Code

52140

Country

Mexico

Facility Name

Local Institution

City

Leon

State/Province

Guanajuato

ZIP/Postal Code

37000

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

42650

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44340

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44690

Country

Mexico

Facility Name

Local Institution

City

Morelia

State/Province

Michioacan

ZIP/Postal Code

58000

Country

Mexico

Facility Name

Local Institution

City

Cuernavaca

State/Province

Morelos

ZIP/Postal Code

62270

Country

Mexico

Facility Name

Local Institution

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64020

Country

Mexico

Facility Name

Local Institution

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

Local Institution

City

San Luis Potosi

ZIP/Postal Code

78240

Country

Mexico

Facility Name

Local Institution

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Local Institution

City

Leiden

ZIP/Postal Code

2300 RC

Country

Netherlands

Facility Name

Local Institution

City

Nijmegen

ZIP/Postal Code

6500 HB

Country

Netherlands

Facility Name

Local Institution

City

Poznan

ZIP/Postal Code

60773

Country

Poland

Facility Name

Local Institution

City

Poznan

ZIP/Postal Code

61-545

Country

Poland

Facility Name

Local Institution

City

Warszawa

ZIP/Postal Code

02-637

Country

Poland

Facility Name

Local Institution

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

Local Institution

City

Bloemfontein

State/Province

Free State

ZIP/Postal Code

9317

Country

South Africa

Facility Name

Local Institution

City

Muckleneuk

State/Province

Gauteng

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Local Institution

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0084

Country

South Africa

Facility Name

Local Institution

City

Berea

State/Province

Kwa Zulu Natal

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Local Institution

City

Panorama

State/Province

Western Cape

ZIP/Postal Code

7506

Country

South Africa

Facility Name

Local Institution

City

A Coruna

ZIP/Postal Code

15706

Country

Spain

Facility Name

Local Institution

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Local Institution

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

Local Institution

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Local Institution

City

Glasgow

State/Province

Lanarkshire

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Local Institution

City

Leeds

State/Province

North Yorkshire

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

Facility Name

Local Institution

City

Newcastle

State/Province

Northumberland

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35418172

Citation

Durez P, Westhovens R, Baeke F, Elbez Y, Robert S, Ahmad HA. Identification of poor prognostic joint locations in an early rheumatoid arthritis cohort at risk of rapidly progressing disease: a post-hoc analysis of the Phase III AGREE study. BMC Rheumatol. 2022 Apr 14;6(1):24. doi: 10.1186/s41927-022-00252-4.

Results Reference

derived

PubMed Identifier

29657830

Citation

Jansen DTSL, Emery P, Smolen JS, Westhovens R, Le Bars M, Connolly SE, Ye J, Toes REM, Huizinga TWJ. Conversion to seronegative status after abatacept treatment in patients with early and poor prognostic rheumatoid arthritis is associated with better radiographic outcomes and sustained remission: post hoc analysis of the AGREE study. RMD Open. 2018 Mar 30;4(1):e000564. doi: 10.1136/rmdopen-2017-000564. eCollection 2018.

Results Reference

derived

PubMed Identifier

26063454

Citation

Smolen JS, Wollenhaupt J, Gomez-Reino JJ, Grassi W, Gaillez C, Poncet C, Le Bars M, Westhovens R. Attainment and characteristics of clinical remission according to the new ACR-EULAR criteria in abatacept-treated patients with early rheumatoid arthritis: new analyses from the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE). Arthritis Res Ther. 2015 Jun 11;17(1):157. doi: 10.1186/s13075-015-0671-9.

Results Reference

derived

PubMed Identifier

21821865

Citation

Bathon J, Robles M, Ximenes AC, Nayiager S, Wollenhaupt J, Durez P, Gomez-Reino J, Grassi W, Haraoui B, Shergy W, Park SH, Genant H, Peterfy C, Becker JC, Covucci A, Moniz Reed D, Helfrick R, Westhovens R. Sustained disease remission and inhibition of radiographic progression in methotrexate-naive patients with rheumatoid arthritis and poor prognostic factors treated with abatacept: 2-year outcomes. Ann Rheum Dis. 2011 Nov;70(11):1949-56. doi: 10.1136/ard.2010.145268. Epub 2011 Aug 6.

Results Reference

derived

Learn more about this trial

Remission and Joint Damage Progression in Early Rheumatoid Arthritis

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Remission and Joint Damage Progression in Early Rheumatoid Arthritis

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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