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Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

etanercept

Placebo

DMARD Therapy

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA, Enbrel, DMARD, Joint Count, Rheumatoid Arthritis, Etanercept, disease modifying anti-rheumatic drug

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female ≥18 and ≤80 years of age at time of screening
Diagnosed with rheumatoid arthritis as determined by meeting 1987 American College of Rheumatology (ACR) classification criteria and has had rheumatoid arthritis for at least 6 months
Moderate rheumatoid arthritis during screening, as defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) > 3.2 and ≤ 5.1
Active rheumatoid arthritis defined as ≥ 3 swollen joints (out of 28 joints examined) and ≥ 3 tender/painful joints (out of 28 joints examined) at screening and baseline. (A full 66/68 count joint count will be performed at baseline, but only joints in the 28-count joint count will be considered for eligibility. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees)
Must be currently taking a DMARD such as methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine

Exclusion Criteria:

Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
Class IV rheumatoid arthritis according to ACR revised response criteria
Any active infection (including chronic or localized infections) for which anti-infectives were indicated within 28 days prior to first investigational product dose
Previously used more than one experimental biologic DMARD. Patient with prior use of no more than one experimental biologic is permitted if the subject received no more than 8 weeks of treatment. The use of the experimental biologic must not have occurred within 2 months of the first dose of investigational product
Previously used more than one commercially available biologic DMARD. Subject with prior use of no more than one commercially available biologic is permitted if the patient received no more than 8 weeks of treatment and did not discontinue because of lack of effect. The use of the biologic must not have occurred within 2 months of the first dose of investigational product. Acceptable prior use of biologics include the following examples:
No more than 4 injections of adalimumab
No more than 8 (50 mg) injections of etanercept
No more than 2 infusions of infliximab
No more than 2 infusions of abatacept
Additional inclusion (exclusion) criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Etanercept

Arm Description

Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.

Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks. All participants continued their DMARD treatment throughout the 24-week study period.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12

Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-Reactive Protein (CRP) level • Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity). The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity.

Secondary Outcome Measures

Percentage of Participants Achieving DAS28 Remission at Week 12

Remission is defined by a DAS28 score less than 2.6. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: The number of swollen and tender joints assessed using the 28-joint count; C-reactive protein (CRP) Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity). The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity.

Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints

Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: The number of swollen and tender joints assessed using the 28-joint count; C-Reactive Protein (CRP) level Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity). The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity.

Percentage of Participants Achieving DAS28 Remission at All Other Timepoints

Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint

A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-Reactive Protein level.

Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint

A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-reactive protein (CRP) level.

Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint

A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-reactive protein (CRP) level.

Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point

The Multi-Dimensional Health Assessment Questionnaire (MDHAQ) is adapted from the standard HAQ and is used for the computation of the Routine Assessment of Patient Index Data 3 (RAPID3). The RAPID 3 includes the 3 Core Data Set measures of physical function, pain, and patient global estimate. The score for physical function ranges from 0 to 10 and is calculated by adding the ten activities of daily living, each scored from 0 to 3 by the patient (0="without any difficulty", 1="with some difficulty", 2="with much difficulty", and 3="unable to do") and dividing the total raw score by 3. Pain and global estimate of health are measured on a likert scale from 0 to 10, both scored 0 (best) to 10 (worst). The three 0-10 scores for physical function, pain, and global assesment of health are added together for a composite score of 0 to 30. The RAPID3 composite score includes 4 categories: High Severity > 12, Moderate Severity = 6.1 - 12, Low severity = 3.1 - 6, and Remission ≤ 3.

Percentage of Participants Achieving Count Remission at Each Time Point

Count remission is achieved when a participant satisfies all of the following at any given time point: - 68 tender joint count ≤ 1, - 66 swollen joint count ≤ 1, - C-reactive protein (CRP) (in mg/dL) ≤1, and - patient global assessment of disease activity ≤ 1 (measured on a likert scale from 0 to 10 ranging from "no activity at all" to "worst activity imaginable").

Percentage of Participants Achieving CDAI Remission at Each Time Point

The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: 28 tender joint count (TJC), 28 swollen joint count (SJC), Patient's Global Assessment of Disease Activity measured on a likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest; Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. CDAI remission is defined as a score ≤ 2.8.

Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point

The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: 28 tender joint count (TJC), 28 swollen joint count (SJC), Patient's Global Assessment of Disease Activity measured on a Likert scale form 0 to 10, where 0 = lowest disease activity and 10 = highest; Physician's Global Assessment of Disease Activity -measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest. The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity. CDAI low disease activity is defined as a score ≤ 10.

Clinical Disease Activity Index (CDAI) Score at Each Time Point

The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: 28 tender joint count (TJC), 28 swollen joint count (SJC), Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest; Physician's Global Assessment of Disease Activity (measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest). The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity.

Percentage of Participants Achieving SDAI Remission at Each Time Point

The simplified disease activity index (SDAI) is a composite measure that sums the total number of: 28 tender joint counts, 28 swollen joint counts, Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0= lowest disease activity and 10 = highest; Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI remission is defined as a score ≤ 3.3.

Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point

The simplified disease activity index (SDAI) is a composite measure that sums the total number of: - 28 tender joint counts, - 28 swollen joint counts, - Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest; - Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest, and - C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI low disease activity is defined as a score ≤ 11.

Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point

The simplified disease activity index (SDAI) is a composite measure that sums the total number of: 28 tender joint counts, 28 swollen joint counts, Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest; Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity.

Tender 28-Joint Count (TJC28) at Each Time Point

Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.

Swollen 28-Joint Count (SJC28) at Each Time Point

Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.

Patient Global Assessment of Joint Pain at Each Time Point

The severity of the participant's joint pain was assessed using a visual analog scale (VAS). The participant was asked to draw a mark through a 100 mm horizontal line to indicate how much pain they were experiencing "today", from '0' (no pain at all) on the left end of the line to 100 (worst pain imaginable) on the right end of the line.

Patient's Global Assessment of Disease Activity at Each Time Point

The participant's global assessment of their arthritis disease activity was assessed by the participant circling a number from 0 to 10 on a horizontal Likert scale ranging from "No Activity at All" (score = 0) to "Worst Activity Imaginable" (score = 10).

Physician Global Assessment of Disease Activity at Each Time Point

The global assessment of the participant's arthritis was assessed by the physician circling a number from 0 to 10 on a horizontal Likert scale ranging from "No Activity at All" (score = 0) to "Worst Activity Imaginable" (score = 10).

Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point

The HAQ-DI asks about the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each functional area are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.

C-reactive Protein Levels at Each Time Point

C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation.

Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The physical functioning subscale assesses limitations in physical activities because of health problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The vitality sub-score assesses energy and fatigue. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The role-physical subscale assesses limitations in usual role activities because of physical health problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning (less pain). Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The mental health sub-score assesses general mental health (psychological distress and well-being). Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point

This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to rheumatoid arthritis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point

This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point

This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis. Percent activity impairment is derived from the patient's assessment of the degree to which rheumatoid arthritis affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point

This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent overall work impairment takes into account both hours missed due to rheumatoid arthritis symptoms and the participant's assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Participant Assessment of Fatigue at Each Time Point

The participant's assessment of fatigue was collected using a single-item 100 mm visual analogue scale. The participant was asked to draw a vertical line through a horizontal line to indicate the degree of fatigue they experienced because of their condition over the past week. The horizontal line is 100 mm in length with '0' and 'no fatigue' on the left end of the line and '100' and 'extreme fatigue' on the right end of the line. Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point

The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). Sleep Disturbance measures the ability to fall asleep and to maintain restful sleep. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point

The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point

The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point

The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Sleep Adequacy measures sleep sufficiency in terms of whether the participant sleeps enough to provide restoration of wakefulness. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. For sleep adequacy a higher score indicates better sleep quality. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point

The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Daytime somnolence measures drowsiness or sleepiness during the day. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point

The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. The Sleep Problems Index-I is drawn from 6 items in the four domains including Sleep Disturbance (2 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point

The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. Index-II uses 9 items from four domains including Sleep Disturbance (4 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (2 items). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Full Information

NCT ID

NCT01313208

First Posted

March 10, 2011

Last Updated

February 7, 2017

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01313208

Brief Title

Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid Arthritis (RA).

6. Conditions and Keywords

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

Rheumatoid Arthritis

Keywords

RA, Enbrel, DMARD, Joint Count, Rheumatoid Arthritis, Etanercept, disease modifying anti-rheumatic drug

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Etanercept

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

etanercept

Other Intervention Name(s)

Enbrel

Intervention Description

Administered by subcutaneous injection once weekly.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

DMARD Therapy

Intervention Description

Standard-of-care DMARD therapy, including methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving DAS28 Remission at Week 12

Description

Time Frame

Week 12

Title

Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints

Description

Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: The number of swollen and tender joints assessed using the 28-joint count; C-Reactive Protein (CRP) level Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity). The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity.

Time Frame

Baseline and Weeks 2, 4, 8, 16, 20 and 24

Title

Percentage of Participants Achieving DAS28 Remission at All Other Timepoints

Description

Time Frame

Baseline and Weeks 2, 4, 8, 16, 20 and 24

Title

Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point

Description

Time Frame

Baseline and Weeks 4, 12, and 24

Title

Percentage of Participants Achieving Count Remission at Each Time Point

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants Achieving CDAI Remission at Each Time Point

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point

Description

The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: 28 tender joint count (TJC), 28 swollen joint count (SJC), Patient's Global Assessment of Disease Activity measured on a Likert scale form 0 to 10, where 0 = lowest disease activity and 10 = highest; Physician's Global Assessment of Disease Activity -measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest. The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity. CDAI low disease activity is defined as a score ≤ 10.

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Clinical Disease Activity Index (CDAI) Score at Each Time Point

Description

The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: 28 tender joint count (TJC), 28 swollen joint count (SJC), Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest; Physician's Global Assessment of Disease Activity (measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest). The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity.

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants Achieving SDAI Remission at Each Time Point

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point

Description

The simplified disease activity index (SDAI) is a composite measure that sums the total number of: 28 tender joint counts, 28 swollen joint counts, Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest; Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity.

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Tender 28-Joint Count (TJC28) at Each Time Point

Description

Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Swollen 28-Joint Count (SJC28) at Each Time Point

Description

Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Patient Global Assessment of Joint Pain at Each Time Point

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Patient's Global Assessment of Disease Activity at Each Time Point

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Physician Global Assessment of Disease Activity at Each Time Point

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

C-reactive Protein Levels at Each Time Point

Description

C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation.

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point

Description

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point

Description

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The vitality sub-score assesses energy and fatigue. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point

Description

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The role-physical subscale assesses limitations in usual role activities because of physical health problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point

Description

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning (less pain). Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point

Description

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point

Description

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point

Description

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point

Description

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The mental health sub-score assesses general mental health (psychological distress and well-being). Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point

Description

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point

Description

This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent impairment while working was derived from the participant's assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point

Description

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point

Description

This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent overall work impairment takes into account both hours missed due to rheumatoid arthritis symptoms and the participant's assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Participant Assessment of Fatigue at Each Time Point

Description

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Title

Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point

Description

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point

Description

The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point

Description

The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point

Description

The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Sleep Adequacy measures sleep sufficiency in terms of whether the participant sleeps enough to provide restoration of wakefulness. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. For sleep adequacy a higher score indicates better sleep quality. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point

Description

The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Daytime somnolence measures drowsiness or sleepiness during the day. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point

Description

The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. The Sleep Problems Index-I is drawn from 6 items in the four domains including Sleep Disturbance (2 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

Title

Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point

Description

The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. Index-II uses 9 items from four domains including Sleep Disturbance (4 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (2 items). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).

Time Frame

Baseline and Weeks 4, 12 and 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female ≥18 and ≤80 years of age at time of screening Diagnosed with rheumatoid arthritis as determined by meeting 1987 American College of Rheumatology (ACR) classification criteria and has had rheumatoid arthritis for at least 6 months Moderate rheumatoid arthritis during screening, as defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) > 3.2 and ≤ 5.1 Active rheumatoid arthritis defined as ≥ 3 swollen joints (out of 28 joints examined) and ≥ 3 tender/painful joints (out of 28 joints examined) at screening and baseline. (A full 66/68 count joint count will be performed at baseline, but only joints in the 28-count joint count will be considered for eligibility. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees) Must be currently taking a DMARD such as methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine Exclusion Criteria: Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening Class IV rheumatoid arthritis according to ACR revised response criteria Any active infection (including chronic or localized infections) for which anti-infectives were indicated within 28 days prior to first investigational product dose Previously used more than one experimental biologic DMARD. Patient with prior use of no more than one experimental biologic is permitted if the subject received no more than 8 weeks of treatment. The use of the experimental biologic must not have occurred within 2 months of the first dose of investigational product Previously used more than one commercially available biologic DMARD. Subject with prior use of no more than one commercially available biologic is permitted if the patient received no more than 8 weeks of treatment and did not discontinue because of lack of effect. The use of the biologic must not have occurred within 2 months of the first dose of investigational product. Acceptable prior use of biologics include the following examples: No more than 4 injections of adalimumab No more than 8 (50 mg) injections of etanercept No more than 2 infusions of infliximab No more than 2 infusions of abatacept Additional inclusion (exclusion) criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Research Site

City

Tuscaloosa

State/Province

Alabama

ZIP/Postal Code

35406

Country

United States

Facility Name

Research Site

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Research Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Research Site

City

Encino

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

Research Site

City

Hemet

State/Province

California

ZIP/Postal Code

92543

Country

United States

Facility Name

Research Site

City

Inglewood

State/Province

California

ZIP/Postal Code

90301

Country

United States

Facility Name

Research Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Research Site

City

Murrieta

State/Province

California

ZIP/Postal Code

92563

Country

United States

Facility Name

Research Site

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

Research Site

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Research Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Research Site

City

Victorville

State/Province

California

ZIP/Postal Code

92395

Country

United States

Facility Name

Research Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Research Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34474

Country

United States

Facility Name

Research Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Research Site

City

Sebring

State/Province

Florida

ZIP/Postal Code

33870

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Research Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Research Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Research Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Research Site

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

Facility Name

Research Site

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

Research Site

City

St. Clair Shores

State/Province

Michigan

ZIP/Postal Code

48081

Country

United States

Facility Name

Research Site

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58501

Country

United States

Facility Name

Research Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44311

Country

United States

Facility Name

Research Site

City

Mayfield Village

State/Province

Ohio

ZIP/Postal Code

44143

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73109

Country

United States

Facility Name

Research Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Research Site

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16508

Country

United States

Facility Name

Research Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78232

Country

United States

Facility Name

Research Site

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

Research Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98133

Country

United States

Facility Name

Research Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M3

Country

Canada

Facility Name

Research Site

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1C 5B8

Country

Canada

Facility Name

Research Site

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7R 1E2

Country

Canada

Facility Name

Research Site

City

Laval

State/Province

Quebec

ZIP/Postal Code

H7T 2P5

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 1S6

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3Z 2Z3

Country

Canada

Facility Name

Research Site

City

Saint-Eustache

State/Province

Quebec

ZIP/Postal Code

J7P 4J2

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25793152

Citation

Hobbs K, Deodhar A, Wang B, Bitman B, Nussbaum J, Chung J, Collier DH. Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etanercept in patients with moderately active rheumatoid arthritis despite DMARD therapy. Springerplus. 2015 Mar 5;4:113. doi: 10.1186/s40064-015-0895-9. eCollection 2015.

Results Reference

background

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)

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Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)

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