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Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis (PRESERVE)

Primary Purpose

Arthritis, Rheumatoid

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Etanercept

Methotrexate

Etanercept

Methotrexate

Placebo

Methotrexate

About this trial

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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of rheumatoid arthritis.
Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.
Active rheumatoid arthritis at the time of screening.

Exclusion Criteria:

Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other than MTX within 28 days before baseline.
Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88

DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joint count (less than [<]20 percent [%] missing SJC or PJC was prorated), erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient's General Health Visual Analog Scale (VAS). VAS is a line 0-100 millimeters (mm) in length; ranged from 0 (very well)-100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units equals (=) low disease activity.

Secondary Outcome Measures

Percentage of Participants Achieving DAS28 Low Disease Activity or Remission at Baseline, Weeks 4, 8, 12, 20, 28 and 36

DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 < 2.6 units = remission.

Percentage of Participants Achieving DAS28 Low Disease Activity or Remission

Change From Baseline in DAS28 at Weeks 4, 8, 12, 20, 28 and 36

The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity measured on a visual analogue scale (VAS) of 100 mm). Change equals (=) Week X observation minus (-) Baseline observation.

Change From Week 36 in DAS28 at Weeks 40, 48, 56, 64, 72, 80 and 88

The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm). Change = Week X observation - Week 36 observation.

Time to Loss of Low Disease Activity DAS28 and a Change of ≥ 0.6 Units in the DAS28

DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. Low disease activity = DAS28 ≤ 3.2 units. DAS28 > 3.2 to 5.1 units = moderate to high disease activity.

Time to Loss of Low Disease Activity DAS28

DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 greater than (>)3.2 to 5.1 units = moderate to high disease activity.

Proportion of Time Participants Had Low Disease Activity DAS28 Week 36 to Week 88

DAS28 calculated from the number of SJC and PJC using the 28 joints, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 < 3.2 units = low disease activity. Cumulative proportion calculated as time-averaged Area Under the Curve (AUC) (AUC divided by number of weeks at that time point), with AUC calculated from Week 36 and Week 88.

Change From Baseline in Prorated Swollen Joint Count at Weeks 4, 8, 12, 20, 28 and 36

American College of Rheumatology (ACR), swollen joint count were an assessment of 28 joints. Joints are classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - baseline observation.

Prorated Swollen Joint Count at Week 36

Change From Week 36 in Prorated Swollen Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88

ACR, swollen joint count was an assessment of 28 joints. Joints were classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation.

Change From Baseline in the Painful Joint Count at Weeks 4, 8, 12, 20, 28 and 36

A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Baseline observation.

Painful Joint Count at Week 36

A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible score ranged form 0-28.

Change From Week 36 in Painful Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88

Total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation.

Change From Baseline in the Physician Global Assessment (PGA) at Weeks 4, 8, 12, 20, 28 and 36

PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Baseline observation.

PGA Score at Week 36

PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity.

Change From Week 36 in the PGA Score at Weeks 40, 48, 56, 64, 72, 80 and 88

PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Week 36 observation.

Change From Baseline in Patient's Global Assessment (PtGA) of Arthritis Pain at Weeks 4, 8, 12, 20, 28 and 36

Participants asked to rate their overall arthritis activity by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Baseline observation.

PtGA of Arthritis Pain at Week 36

PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity).

Change From Week 36 in PtGA of Arthritis Pain at Weeks 40, 48, 56, 64, 72, 80, 88

PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Week 36 observation.

Change From Baseline in Duration of Morning Stiffness at Weeks 4, 8, 12, 20, 28 and 36

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and when the participants were able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour times [*] 60 min) was recorded. Change = Week X observation - Baseline observation.

Duration of Morning Stiffness at Week 36

Change From Week 36 in Duration of Morning Stiffness at Weeks 40, 48, 56, 64, 72, 80, 88

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour * 60 min) was recorded. Change = Week X observation - Week 36 observation.

Change From Baseline in General Health at Weeks 4, 8, 12, 20, 28 and 36

General Health VAS is a 100 millimeter (mm) line marked by the participant. Participants were asked, "In general how would you rate your health over the last 2 to 3 weeks?" Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Baseline observation.

General Health at Week 36

General Health VAS is a 100 mm line marked by the participant. Participants are asked, "In general how would you rate your health over the last 2 to 3 weeks?" Scores ranged from 0 mm = very well to 100 mm = extremely bad.

Change From Week 36 in General Health at Weeks 40, 48, 56, 64, 72, 80, 88

General Health VAS is a 100 mm line marked by the participant. Participants were asked, "In general how would you rate your health over the last 2 to 3 weeks?" Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Week 36 observation.

Change From Baseline in Pain at Weeks 4, 8, 12, 20, 28 and 36

100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation - Baseline observation.

Pain at Week 36

100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = pain as bad as it could be. Change = Week x observation minus (-) Baseline observation.

Change From Week 36 in Pain at Weeks 40, 48, 56, 64, 72, 80 and 88

100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation - Week 36 observation.

Percentage of Participants Achieving an Acceptable State on the Patient Acceptable Symptom State (PASS) at Baseline and Week 36

PASS was a 1 question assessment of how rheumatoid arthritis has affected the participant in the last 2 days (If you were to remain in the next few months as you were during the last 2 days, would this be acceptable or unacceptable to you?).

Percentage of Participants Achieving an Acceptable State on the PASS at Week 36 and Weeks 64 and 88

Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good or Moderate Response at Weeks 4, 8, 12, 20, 28 and 36

EULAR Response Criteria: Good response was defined as >1.2 units improvement in DAS28 from Baseline and DAS28 attained up to Week 88 of <=3.2 units. Non responders were participants with improvement of <0.6 units or participants with improvement of 0.6 to 1.2 units and DAS28 attained up to Week 88 of > 5.1 units. Remaining participants were defined as having a moderate response. Scores of good and moderate were considered to have therapeutic response.

Percentage of Participants Achieving EULAR Good or Moderate Response at Week 36, 40, 48, 56, 64, 72, 80 and 88

Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 4, 8, 12, 20, 28 and 36

ACR20 response, ≥ 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and = at least 20% improvement in at least 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant 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 (ESR).

Percentage of Participants With an ACR20 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88

ACR20 response: ≥ 20% improvement in tender joint count; ≥20% improvement in swollen joint count; and = at least 20% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).

Percentage of Participants With an ACR50 Response at Weeks 4, 8, 12, 20, 28 and 36

ACR50 response: ≥ 50% improvement in tender joint count; = ≥50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).

Percentage of Participants With an ACR50 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Percentage of Participants With an ACR70 Response at Weeks 4, 8, 12, 20, 28 and 36

ACR70 response: ≥ 70% improvement in tender joint count; = ≥70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).

Percentage of Participants With an ACR70 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Percentage of Participants With an ACR90 Response at Weeks 4, 8, 12, 20, 28 and 36

ACR90 response: ≥ 90% improvement in tender joint count; = ≥90% improvement in swollen joint count; and = at least 90% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).

Percentage of Participants With an ACR90 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88

ACR90 response: ≥ 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: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR).

DAS28 at Week 36

Full Information

NCT ID

NCT00565409

First Posted

November 28, 2007

Last Updated

August 4, 2015

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00565409

Brief Title

Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

Acronym

PRESERVE

Official Title

A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.

6. Conditions and Keywords

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

Arthritis, Rheumatoid

Keywords

Active Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

834 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Etanercept

Other Intervention Name(s)

Enbrel

Intervention Description

Subcutaneous (SC), 50 mg, once weekly for 88 weeks

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks. If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).

Intervention Type

Drug

Intervention Name(s)

Etanercept

Intervention Description

Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subcutaneous (SC), once weekly from week 36 to week 88.

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88

Description

Time Frame

Week 88

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving DAS28 Low Disease Activity or Remission at Baseline, Weeks 4, 8, 12, 20, 28 and 36

Description

Time Frame

Baseline, Weeks 4, 8, 12, 20, 28, 36

Title

Percentage of Participants Achieving DAS28 Low Disease Activity or Remission

Description

Time Frame

Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Title

Change From Baseline in DAS28 at Weeks 4, 8, 12, 20, 28 and 36

Description

Time Frame

Baseline, Weeks 4, 8, 12, 20, 28 and 36

Title

Change From Week 36 in DAS28 at Weeks 40, 48, 56, 64, 72, 80 and 88

Description

The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm). Change = Week X observation - Week 36 observation.

Time Frame

Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Title

Time to Loss of Low Disease Activity DAS28 and a Change of ≥ 0.6 Units in the DAS28

Description

Time Frame

Week 36 up to Week 88

Title

Time to Loss of Low Disease Activity DAS28

Description

DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 greater than (>)3.2 to 5.1 units = moderate to high disease activity.

Time Frame

Week 36 up to Week 88

Title

Proportion of Time Participants Had Low Disease Activity DAS28 Week 36 to Week 88

Description

Time Frame

Week 36 up to Week 88

Title

Change From Baseline in Prorated Swollen Joint Count at Weeks 4, 8, 12, 20, 28 and 36

Description

Time Frame

Baseline, Weeks 4, 8, 12, 20, 28 and 36

Title

Prorated Swollen Joint Count at Week 36

Description

Time Frame

Week 36

Title

Change From Week 36 in Prorated Swollen Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88

Description

Time Frame

Week 36, Weeks 40, 48, 56, 64, 72, 80 and 88

Title

Change From Baseline in the Painful Joint Count at Weeks 4, 8, 12, 20, 28 and 36

Description

Time Frame

Baseline, Weeks 4, 8, 12, 20, 28 and 36

Title

Painful Joint Count at Week 36

Description

A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible score ranged form 0-28.

Time Frame

Week 36

Title

Change From Week 36 in Painful Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88

Description

Time Frame

Weeks 36 40, 48, 56, 64, 72, 80 and 88

Title

Change From Baseline in the Physician Global Assessment (PGA) at Weeks 4, 8, 12, 20, 28 and 36

Description

PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Baseline observation.

Time Frame

Baseline, Weeks 4, 8, 12, 20, 28 and 36

Title

PGA Score at Week 36

Description

PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity.

Time Frame

Week 36

Title

Change From Week 36 in the PGA Score at Weeks 40, 48, 56, 64, 72, 80 and 88

Description

PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Week 36 observation.

Time Frame

Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Title

Change From Baseline in Patient's Global Assessment (PtGA) of Arthritis Pain at Weeks 4, 8, 12, 20, 28 and 36

Description

Time Frame

Baseline, Weeks 4, 8, 12, 20, 28 and 36

Title

PtGA of Arthritis Pain at Week 36

Description

PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity).

Time Frame

Week 36

Title

Change From Week 36 in PtGA of Arthritis Pain at Weeks 40, 48, 56, 64, 72, 80, 88

Description

Time Frame

Weeks 36, 40, 48, 56, 64, 72, 80, 88

Title

Change From Baseline in Duration of Morning Stiffness at Weeks 4, 8, 12, 20, 28 and 36

Description

Time Frame

Baseline, Weeks 4, 8, 12, 20, 28 and 36

Title

Duration of Morning Stiffness at Week 36

Description

Time Frame

Week 36

Title

Change From Week 36 in Duration of Morning Stiffness at Weeks 40, 48, 56, 64, 72, 80, 88

Description

Time Frame

Weeks 36, 40, 48, 56, 64, 72, 80, 88

Title

Change From Baseline in General Health at Weeks 4, 8, 12, 20, 28 and 36

Description

Time Frame

Baseline, Weeks 4, 8, 12, 20, 28 and 36

Title

General Health at Week 36

Description

Time Frame

Week 36

Title

Change From Week 36 in General Health at Weeks 40, 48, 56, 64, 72, 80, 88

Description

Time Frame

Weeks 36, 40, 48, 56, 64, 72, 80, 88

Title

Change From Baseline in Pain at Weeks 4, 8, 12, 20, 28 and 36

Description

100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation - Baseline observation.

Time Frame

Baseline, Weeks 4, 8, 12, 20, 28 and 36

Title

Pain at Week 36

Description

Time Frame

Week 36

Title

Change From Week 36 in Pain at Weeks 40, 48, 56, 64, 72, 80 and 88

Description

100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation - Week 36 observation.

Time Frame

Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Title

Percentage of Participants Achieving an Acceptable State on the Patient Acceptable Symptom State (PASS) at Baseline and Week 36

Description

Time Frame

Baseline, Week 36

Title

Percentage of Participants Achieving an Acceptable State on the PASS at Week 36 and Weeks 64 and 88

Description

Time Frame

Weeks 36, 64 and 88

Title

Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good or Moderate Response at Weeks 4, 8, 12, 20, 28 and 36

Description

Time Frame

Weeks 4, 8, 12, 20, 28 and 36

Title

Percentage of Participants Achieving EULAR Good or Moderate Response at Week 36, 40, 48, 56, 64, 72, 80 and 88

Description

Time Frame

Week 36, 40, 48, 56, 64, 72, 80 and 88

Title

Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 4, 8, 12, 20, 28 and 36

Description

Time Frame

Weeks 4, 8, 12, 20, 28 and 36

Title

Percentage of Participants With an ACR20 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Description

Time Frame

Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Title

Percentage of Participants With an ACR50 Response at Weeks 4, 8, 12, 20, 28 and 36

Description

Time Frame

Weeks 4, 8, 12, 20, 28 and 36

Title

Percentage of Participants With an ACR50 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Description

Time Frame

Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Title

Percentage of Participants With an ACR70 Response at Weeks 4, 8, 12, 20, 28 and 36

Description

Time Frame

Weeks 4, 8, 12, 20, 28 and 36

Title

Percentage of Participants With an ACR70 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Description

Time Frame

Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Title

Percentage of Participants With an ACR90 Response at Weeks 4, 8, 12, 20, 28 and 36

Description

Time Frame

Weeks 4, 8, 12, 20, 28 and 36

Title

Percentage of Participants With an ACR90 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Description

Time Frame

Weeks 36, 40, 48, 56, 64, 72, 80 and 88

Title

DAS28 at Week 36

Description

Time Frame

Week 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of rheumatoid arthritis. Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis. Active rheumatoid arthritis at the time of screening. Exclusion Criteria: Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents. Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other than MTX within 28 days before baseline. Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Campsie

State/Province

New South Wales

ZIP/Postal Code

2194

Country

Australia

Facility Name

Pfizer Investigational Site

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Pfizer Investigational Site

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Pfizer Investigational Site

City

Daw Park

State/Province

South Australia

ZIP/Postal Code

5041

Country

Australia

Facility Name

Pfizer Investigational Site

City

Heidelberg West

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

Pfizer Investigational Site

City

Malvern

State/Province

Victoria

ZIP/Postal Code

3145

Country

Australia

Facility Name

Pfizer Investigational Site

City

Victoria Park

ZIP/Postal Code

6100

Country

Australia

Facility Name

Pfizer Investigational Site

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Pfizer Investigational Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Santiago

State/Province

Region Metropolitana

Country

Chile

Facility Name

Pfizer Investigational Site

City

Barranquilla

State/Province

Atlantico

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Brno

ZIP/Postal Code

656 91

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Bruntal

ZIP/Postal Code

792 01

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Bruntal

ZIP/Postal Code

79201

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Praha 2

ZIP/Postal Code

128 50

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Praha 5

ZIP/Postal Code

150 06

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Zlin

ZIP/Postal Code

760 01

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Former Serbia and Montenegro

Facility Name

Pfizer Investigational Site

City

Niska Banja

ZIP/Postal Code

18205

Country

Former Serbia and Montenegro

Facility Name

Pfizer Investigational Site

City

Corbeil-Essonnes

ZIP/Postal Code

91100

Country

France

Facility Name

Pfizer Investigational Site

City

Le Kremlin Bicetre

ZIP/Postal Code

94270

Country

France

Facility Name

Pfizer Investigational Site

City

Le Mans

ZIP/Postal Code

72037

Country

France

Facility Name

Pfizer Investigational Site

City

Montpellier

ZIP/Postal Code

34059

Country

France

Facility Name

Pfizer Investigational Site

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

Pfizer Investigational Site

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Facility Name

Pfizer Investigational Site

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hamburg-Eilbek

ZIP/Postal Code

22081

Country

Germany

Facility Name

Pfizer Investigational Site

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leipzig

ZIP/Postal Code

4103

Country

Germany

Facility Name

Pfizer Investigational Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Pfizer Investigational Site

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Debrecen

ZIP/Postal Code

4012

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Debrecen

ZIP/Postal Code

H-4032

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Szombathely

ZIP/Postal Code

9701

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Catania

State/Province

ZIP/Postal Code

95100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Orbassano

State/Province

ZIP/Postal Code

10043

Country

Italy

Facility Name

Pfizer Investigational Site

City

Roma

ZIP/Postal Code

00128

Country

Italy

Facility Name

Pfizer Investigational Site

City

Seo-gu

State/Province

Daejeon

ZIP/Postal Code

302-799

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Namdong-gu

State/Province

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

State/Province

Korea

ZIP/Postal Code

135-720

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seongdong-gu

State/Province

Seoul

ZIP/Postal Code

133-792

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Anyang-si Gyeonggi-do

ZIP/Postal Code

431-070

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

134-701

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

143-729

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97000

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Guadalajara

ZIP/Postal Code

44650

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Mexico City

ZIP/Postal Code

06700

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Mexico DF

ZIP/Postal Code

11500

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Monterrey

ZIP/Postal Code

64020

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Queretaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Heerlen

ZIP/Postal Code

6419 PC

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Pfizer Investigational Site

City

Lodz

ZIP/Postal Code

93-513

Country

Poland

Facility Name

Pfizer Investigational Site

City

Lublin

ZIP/Postal Code

20-954

Country

Poland

Facility Name

Pfizer Investigational Site

City

Szczecin

ZIP/Postal Code

71-252

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

Country

Poland

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

119002

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

St Petersburg

ZIP/Postal Code

199004

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

St. Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Santiago de Compostela

State/Province

A Coruña

ZIP/Postal Code

157 06

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Pfizer Investigational Site

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Pfizer Investigational Site

City

Malaga

ZIP/Postal Code

29009

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Pfizer Investigational Site

City

Falun

ZIP/Postal Code

79182

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Oskarström

ZIP/Postal Code

31392

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Tapei City

State/Province

ROC

ZIP/Postal Code

114

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Kaohsiung City

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Wigan

State/Province

Lancashire

ZIP/Postal Code

WN6 9EP

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Dudley

State/Province

West Midlands

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

31277720

Citation

Tanaka Y, Smolen JS, Jones H, Szumski A, Marshall L, Emery P. The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis. Arthritis Res Ther. 2019 Jul 5;21(1):164. doi: 10.1186/s13075-019-1937-4.

Results Reference

derived

PubMed Identifier

31257453

Citation

Smolen JS, Pedersen R, Jones H, Mahgoub E, Marshall L. Impact of flare on radiographic progression after etanercept continuation, tapering or withdrawal in patients with rheumatoid arthritis. Rheumatology (Oxford). 2020 Jan 1;59(1):153-164. doi: 10.1093/rheumatology/kez224.

Results Reference

derived

PubMed Identifier

29338762

Citation

Smolen JS, Szumski A, Koenig AS, Jones TV, Marshall L. Predictors of remission with etanercept-methotrexate induction therapy and loss of remission with etanercept maintenance, reduction, or withdrawal in moderately active rheumatoid arthritis: results of the PRESERVE trial. Arthritis Res Ther. 2018 Jan 16;20(1):8. doi: 10.1186/s13075-017-1484-9.

Results Reference

derived

PubMed Identifier

27209012

Citation

Smolen JS, Strand V, Koenig AS, Szumski A, Kotak S, Jones TV. Discordance between patient and physician assessments of global disease activity in rheumatoid arthritis and association with work productivity. Arthritis Res Ther. 2016 May 21;18(1):114. doi: 10.1186/s13075-016-1004-3.

Results Reference

derived

PubMed Identifier

23332236

Citation

Smolen JS, Nash P, Durez P, Hall S, Ilivanova E, Irazoque-Palazuelos F, Miranda P, Park MC, Pavelka K, Pedersen R, Szumski A, Hammond C, Koenig AS, Vlahos B. Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial. Lancet. 2013 Mar 16;381(9870):918-29. doi: 10.1016/S0140-6736(12)61811-X. Epub 2013 Jan 17.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881A1-4423&StudyName=Study%20Comparing%20Etanercept%20in%20Combination%20with%20Methotrexate%20in%20Subjects%20With%20Rheumatoid%20Arthritis

Description

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Learn more about this trial

Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

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Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis (PRESERVE)

Arthritis, Rheumatoid

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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