search
Back to results

Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
etanercept (EnbrelTM)
methotrexate
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
  • Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
  • Have received MTX as stable dose for 28 days prior to the screening visit.

Exclusion Criteria:

  • Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF) -a inhibitors, anakinra or other biological agents.
  • Receipt of any DMARD, other than MTX, within 28 days before screening.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Usual care

ETN + MTX

Arm Description

Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).

Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).

Outcomes

Primary Outcome Measures

Change From Baseline in Modified Total Sharp Score (TSS) at Week 52
Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.

Secondary Outcome Measures

Change From Baseline in Erosions at Week 52
Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Change From Baseline in Joint Space Narrowing at Week 52
Joint space narrowing score (a component of the modified TSS) is a measure of change in joint health. Joint space narrowing score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Percentage of Participants Showing no Radiographic Progression (TSS Change <0.5) at Week 52
Radiographic non-progression determined based on TSS change <0.5 using the dichotomous response Yes / No. The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Percentage of Participants Achieving >1.2 Improvement in Disease Activity Score Based on a 28-joint Count (DAS28)
Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using Visual Analog Scale (VAS); range 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 square root (√) (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.1=higher disease activity; <3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (change in DAS28 < -1.2).
Percentage of Participants Achieving Remission (DAS28 <2.60)
Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.
Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.20)
Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.
Percentage of Participants Achieving a >0.6 Disease Activity Score (DAS)28 Response
Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and participant's assessment of general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission. DAS28 response of >0.6 defined as decrease in DAS28 >0.6 (change in DAS28 < -0.6).
Percentage of Participants Achieving Moderate or Good Response on European League Against Rheumatism (EULAR) Response Criteria
Response to treatment assessed by EULAR response criteria. Participants were characterized as good, moderate, or non-responders based on both Disease Activity Score (DAS) level attained and change in DAS. Good response defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders = participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >5.1. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
American College of Rheumatology 20% (ACR20) response: responder = ≥ 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 erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
American College of Rheumatology 50% (ACR50) response: responder = ≥ 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 erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
American College of Rheumatology 70% (ACR70) response: responder = ≥ 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 erythrocyte sedimentation rate (ESR) . Subjects withdrawing early were non-responders.
Percentage of Participants With American College of Rheumatology 90% (ACR90) Response
American College of Rheumatology 90% (ACR 90) response: responder = ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% 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 erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.
Change From Baseline in Mean Daily Dose of Corticosteroids to Manage Flare-ups Across the 52-week Treatment Period
Mean daily dose of corticosteroids to manage flare-ups (temporary increases in corticosteroid dose or use of intra-articular steroids) during treatment period. Daily dose of equivalent prednisone derived in mg/day: oral corticosteroids: 5 mg of prednisone = 5 mg of prednisolone = 25 mg of cortisone = 20 mg of hydrocortisone = 4 mg of methylprednisolone = 4 mg of triamcinolone = 2mg of paramethasone = 0.75 mg of betamethasone = 0.75 of dexamethasone = 0.3 of cortivazol.
Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII)
Participants were asked how their pain had been during the last 48 hours compared to baseline. Participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.
Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS)
Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours.
Health Related Quality of Life: EuroQol-5D Health Index
EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.
Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.

Full Information

First Posted
June 25, 2008
Last Updated
June 16, 2011
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00706797
Brief Title
Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects
Official Title
An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Moderate Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
Arm Title
ETN + MTX
Arm Type
Active Comparator
Arm Description
Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
Intervention Type
Drug
Intervention Name(s)
etanercept (EnbrelTM)
Intervention Type
Drug
Intervention Name(s)
methotrexate
Primary Outcome Measure Information:
Title
Change From Baseline in Modified Total Sharp Score (TSS) at Week 52
Description
Modified TSS is a measure of change in joint health. TSS is defined as joint space narrowing score (range 0 [no narrowing] to 168 [high narrowing]) plus (+) erosion score (range is from 0 [no erosion] to 280 [high erosion]). The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame
Baseline, Week 52
Secondary Outcome Measure Information:
Title
Change From Baseline in Erosions at Week 52
Description
Erosion score (a component of the modified TSS) is a measure of change in joint health. Erosion score range is from 0 (no erosion) to 280 (high erosion). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame
Baseline, Week 52
Title
Change From Baseline in Joint Space Narrowing at Week 52
Description
Joint space narrowing score (a component of the modified TSS) is a measure of change in joint health. Joint space narrowing score range is 0 (no narrowing) to 168 (high narrowing). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame
Baseline, Week 52
Title
Percentage of Participants Showing no Radiographic Progression (TSS Change <0.5) at Week 52
Description
Radiographic non-progression determined based on TSS change <0.5 using the dichotomous response Yes / No. The modified TSS range is from 0 (no damage) to 448 (bad joint status). Increase from baseline represents disease progression and / or joint worsening; no change represents halting of disease progression; a decrease represents improvement.
Time Frame
Baseline, Week 52, Last observation carried forward (LOCF)
Title
Percentage of Participants Achieving >1.2 Improvement in Disease Activity Score Based on a 28-joint Count (DAS28)
Description
Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using Visual Analog Scale (VAS); range 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 square root (√) (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.1=higher disease activity; <3.2=low disease activity; <2.6=clinical remission. Achievement of >1.2 improvement defined as decrease in DAS28 >1.2 (change in DAS28 < -1.2).
Time Frame
Baseline, Week 12, Week 24, and Week 52
Title
Percentage of Participants Achieving Remission (DAS28 <2.60)
Description
Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.
Time Frame
Week 12, Week 24, and Week 52
Title
Percentage of Participants Achieving Low Disease Activity (DAS28 ≤3.20)
Description
Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission.
Time Frame
Week 12, Week 24, and Week 52
Title
Percentage of Participants Achieving a >0.6 Disease Activity Score (DAS)28 Response
Description
Disease activity score based on 28 painful joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR) mm/hr, and participant's assessment of general health (GH) using a visual analog scale (VAS); VAS range: 0 (very well) to 100 (extremely bad). DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH; range 0 to 10. DAS28 score >5.10=higher disease activity; <3.20=low disease activity; <2.60=clinical remission. DAS28 response of >0.6 defined as decrease in DAS28 >0.6 (change in DAS28 < -0.6).
Time Frame
Week 12, Week 24, and Week 52
Title
Percentage of Participants Achieving Moderate or Good Response on European League Against Rheumatism (EULAR) Response Criteria
Description
Response to treatment assessed by EULAR response criteria. Participants were characterized as good, moderate, or non-responders based on both Disease Activity Score (DAS) level attained and change in DAS. Good response defined as >1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders = participants with improvement of ≤0.6 or participants with improvement of >0.6 but ≤1.2 and DAS attained during follow-up of >5.1. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.
Time Frame
Week 12, Week 24, Week 52
Title
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
Description
American College of Rheumatology 20% (ACR20) response: responder = ≥ 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 erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.
Time Frame
Week 12, Week 24, Week 52
Title
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Description
American College of Rheumatology 50% (ACR50) response: responder = ≥ 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 erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.
Time Frame
Week 12, Week 24, Week 52
Title
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Description
American College of Rheumatology 70% (ACR70) response: responder = ≥ 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 erythrocyte sedimentation rate (ESR) . Subjects withdrawing early were non-responders.
Time Frame
Week 12, Week 24, Week 52
Title
Percentage of Participants With American College of Rheumatology 90% (ACR90) Response
Description
American College of Rheumatology 90% (ACR 90) response: responder = ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% 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 erythrocyte sedimentation rate (ESR). Subjects withdrawing early were non-responders.
Time Frame
Week 12, Week 24, Week 52
Title
Change From Baseline in Mean Daily Dose of Corticosteroids to Manage Flare-ups Across the 52-week Treatment Period
Description
Mean daily dose of corticosteroids to manage flare-ups (temporary increases in corticosteroid dose or use of intra-articular steroids) during treatment period. Daily dose of equivalent prednisone derived in mg/day: oral corticosteroids: 5 mg of prednisone = 5 mg of prednisolone = 25 mg of cortisone = 20 mg of hydrocortisone = 4 mg of methylprednisolone = 4 mg of triamcinolone = 2mg of paramethasone = 0.75 mg of betamethasone = 0.75 of dexamethasone = 0.3 of cortivazol.
Time Frame
Week 4, Week 12, Week 24, Week 40, Week 52
Title
Percentage of Participants Achieving a Minimal Clinically Important Improvement (MCII)
Description
Participants were asked how their pain had been during the last 48 hours compared to baseline. Participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more pain.
Time Frame
Week 12, Week 52
Title
Percentage of Participants Achieving a Patient Acceptable Symptom State (PASS)
Description
Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours.
Time Frame
Week 4, Week 12, Week 24, Week 40, Week 52
Title
Health Related Quality of Life: EuroQol-5D Health Index
Description
EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.
Time Frame
Baseline, Week 12, Week 24, and Week 52
Title
Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)
Description
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Time Frame
Baseline, Week 12, Week 24, and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis. Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit. Have received MTX as stable dose for 28 days prior to the screening visit. Exclusion Criteria: Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF) -a inhibitors, anakinra or other biological agents. Receipt of any DMARD, other than MTX, within 28 days before screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Ostrava
ZIP/Postal Code
722 00
Country
Czech Republic
City
Prague
ZIP/Postal Code
128-50
Country
Czech Republic
City
Prague
ZIP/Postal Code
140-59
Country
Czech Republic
City
Amiens cedex 1
ZIP/Postal Code
80054
Country
France
City
Amiens
ZIP/Postal Code
80054
Country
France
City
Echirolles
ZIP/Postal Code
38130
Country
France
City
Metz
ZIP/Postal Code
57077
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Paris cedex 13
ZIP/Postal Code
75651
Country
France
City
Paris cedex 14
ZIP/Postal Code
75679
Country
France
City
Paris
ZIP/Postal Code
75651
Country
France
City
Paris
ZIP/Postal Code
75679
Country
France
City
Rouen
ZIP/Postal Code
76031
Country
France
City
Tours cedex 9
ZIP/Postal Code
37044
Country
France
City
Tours
ZIP/Postal Code
37044
Country
France
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
City
Hamburg-Eilbeck
ZIP/Postal Code
22081
Country
Germany
City
Homburg
ZIP/Postal Code
66424
Country
Germany
City
Koeln
ZIP/Postal Code
50924
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
City
Rijeka
ZIP/Postal Code
51000
Country
Hungary
City
Split
ZIP/Postal Code
21000
Country
Hungary
City
Zagreb
ZIP/Postal Code
10000
Country
Hungary
City
Jesi (Ancona)
ZIP/Postal Code
60035
Country
Italy
City
Reggio Calabria
ZIP/Postal Code
89100
Country
Italy
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
City
Ustron
ZIP/Postal Code
43-450
Country
Poland
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28902
Country
Spain
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
City
Cambridge
State/Province
Cambs
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
City
Aintree
ZIP/Postal Code
L9 7AL
Country
United Kingdom
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
City
Wirral
ZIP/Postal Code
CH49 5PE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23213004
Citation
Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Clinical and ultrasound-based composite disease activity indices in rheumatoid arthritis: results from a multicenter, randomized study. Arthritis Care Res (Hoboken). 2013 Jun;65(6):879-87. doi: 10.1002/acr.21913.
Results Reference
derived
PubMed Identifier
22131049
Citation
Mandl P, Balint PV, Brault Y, Backhaus M, D'Agostino MA, Grassi W, van der Heijde D, de Miguel E, Wakefield RJ, Logeart I, Dougados M. Metrologic properties of ultrasound versus clinical evaluation of synovitis in rheumatoid arthritis: results of a multicenter, randomized study. Arthritis Rheum. 2012 Apr;64(4):1272-82. doi: 10.1002/art.33491. Epub 2011 Nov 30.
Results Reference
derived

Learn more about this trial

Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects

We'll reach out to this number within 24 hrs