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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01783015
Registration number
NCT01783015
Ethics application status
Date submitted
31/01/2013
Date registered
4/02/2013
Date last updated
6/01/2016
Titles & IDs
Public title
Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate
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Scientific title
A Randomized, Double-blind, Placebo-controlled Study Of The Safety And Efficacy Of Etanercept In Subjects With Rheumatoid Arthritis Who Have Had An Inadequate Response To Adalimumab Or Infliximab Plus Methotrexate
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Secondary ID [1]
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2012-003644-71
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Secondary ID [2]
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B1801355
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Universal Trial Number (UTN)
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Trial acronym
SERUM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Etanercept
Treatment: Drugs - Etanercept
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Experimental: Group A - Subjects who are mAb ADA positive
Experimental: Group B - Subjects who are mAb ADA negative
Placebo Comparator: Group C - Subjects who are mAb ADA positive
Placebo Comparator: Group D - Subjects who are mAb ADA negative
Treatment: Drugs: Etanercept
Etanercept 50 mg once-weekly
Treatment: Drugs: Etanercept
Etanercept 50 mg once-weekly
Treatment: Drugs: Placebo
Etanercept placebo once-weekly
Treatment: Drugs: Placebo
Etanercept placebo once-weekly
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in the Disease Activity Score Based on a 28 Joint Count (DAS28-C-reactive Protein [CRP]) at Week 12.
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Assessment method [1]
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DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the c-reactive protein (CRP) and Subject General Health Visual Analogue Scale (VAS) assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).
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Timepoint [1]
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Baseline, 12 weeks
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Secondary outcome [1]
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Change From Baseline in the DAS28 at Week 24
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Assessment method [1]
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DAS28 calculated from the number of SJC and PJC using the 28 joints count, the CRP and and Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).
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Timepoint [1]
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Baseline, 24 weeks
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Secondary outcome [2]
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Number of Participants With DAS28 <3.2
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Assessment method [2]
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Number of participants with DAS28 <3.2. A score of < 3.2 implied low disease activity.
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Timepoint [2]
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12 weeks, 24 weeks
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Secondary outcome [3]
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Number of Participants With DAS28 <2.6
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Assessment method [3]
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Number of Participants with DAS28 <2.6. A DAS28 < 2.6 implies remission.
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Timepoint [3]
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12 weeks, 24 weeks
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Secondary outcome [4]
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Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response
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Assessment method [4]
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ACR20 response: greater than or equal to (=) 20 percent (%) improvement in tender joint count; = 20% improvement in swollen joint count; and = 20% improvement in at least 3 of 5 remaining ACR core measures: participant's assessment of pain; Subject Global Assessment (SGA) of disease activity; Physician Global Assessment (PGA) of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.
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Timepoint [4]
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12 weeks, 24 weeks
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Secondary outcome [5]
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Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
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Assessment method [5]
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ACR50 response: greater than or equal to (=) 50 percent (%) improvement in tender or swollen joint counts and = 50% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.
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Timepoint [5]
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12 weeks, 24 weeks
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Secondary outcome [6]
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Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
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Assessment method [6]
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ACR70 response: greater than or equal to (=) 70 percent (%) improvement in tender or swollen joint counts and = 70% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.
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Timepoint [6]
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12 weeks, 24 weeks
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Secondary outcome [7]
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Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response
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Assessment method [7]
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ACR90 response: greater than or equal to (=) 90 percent (%) improvement in tender or swollen joint counts and = 90% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.
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Timepoint [7]
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12 weeks, 24 weeks
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Secondary outcome [8]
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Number of Participants Achieving European League Against Rheumatism (EULAR) Good and/or Moderate Response.
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Assessment method [8]
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The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.
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Timepoint [8]
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12 weeks, 24 weeks
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Secondary outcome [9]
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Number of Participants Achieving Low Disease Activity or Remission Based on Clinical Disease Activity Index (CDAI)
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Assessment method [9]
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The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
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Timepoint [9]
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12 weeks, 24 weeks
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Secondary outcome [10]
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Number of Participants Achieving Low Disease Activity or Remission Based on Simplified Disease Activity Index (SDAI).
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Assessment method [10]
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The SDAI is the numerical sum of five outcome parameters: TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
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Timepoint [10]
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12 weeks, 24 weeks
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Secondary outcome [11]
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Change From Baseline in CDAI
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Assessment method [11]
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Change from Baseline in CDAI scores was to be calculated. The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
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Timepoint [11]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [12]
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Change From Baseline in SDAI.
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Assessment method [12]
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Change from Baseline in SDAI scores were to be calculated. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
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Timepoint [12]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [13]
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Change From Baseline in Number of Tender/Painful Joints
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Assessment method [13]
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Change from Baseline in the number of tender/painful joints using the 28 joint count including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.
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Timepoint [13]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [14]
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Change From Baseline in Number of Swollen Joints
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Assessment method [14]
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Change from Baseline in the number of swollen joints including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.
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Timepoint [14]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [15]
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Change From Baseline in Physician Global Assessment of Disease Activity
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Assessment method [15]
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Change from Baseline in the PGA scores was to be estimated. The Study Physician estimated the participant's overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).
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Timepoint [15]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [16]
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Change From Baseline in Subject Global Assessment of Disease Activity
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Assessment method [16]
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Change from Baseline in Subject Global Assessment of Disease Activity was to be estimated. Participants were to assess their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).
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Timepoint [16]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [17]
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Change From Baseline in Subject General Health VAS.
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Assessment method [17]
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Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).
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Timepoint [17]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [18]
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Change From Baseline in Subject Pain
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Assessment method [18]
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Subject Pain was to be measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no pain and 100 mm = most severe pain.
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Timepoint [18]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [19]
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Change From Baseline in CRP
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Assessment method [19]
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The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
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Timepoint [19]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [20]
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Change From Baseline in Health Assessment Questionnaire Disability and Discomfort Scales (HAQ-DI)
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Assessment method [20]
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Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
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Timepoint [20]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [21]
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Change From Baseline in Euro Quality of Life (Qol) EQ-5 Dimensions Questionnaire (EQ-5D)
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Assessment method [21]
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The EuroQol-5 Dimensions (EQ-5D) is a participant-completed questionnaire designed to assess health related quality of life. There are 2 components to the EQ-5D: a Health State Profile and a VAS. For the Health State Profile, participants recorded their level of current health for 5 domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores from the 5 domains may be used to calculate a single index value, also known as a utility score. On the VAS participants were asked to rate their current health on a scale from 0 to 100 mm, where 0 represented the "worst imaginable health state" and 100 represented the "best imaginable health state." In addition to a summary of mean changes, 1 categorical endpoint each based on EQ-5D utility score and 1 based on the VAS were derived and analyzed: EQ-5D utility score improvement =0.05 and EQ-5D VAS score >82.
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Timepoint [21]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [22]
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Change From Baseline in Short Form-36 Health Survey (SF-36)
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Assessment method [22]
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The 36-Item Short Form Health Survey (SF-36) is widely used 36-item questionnaire that measures general health-related quality of life in the following 8 domains: physical function, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitation due to emotional problems, and mental health. Scores for the 8 domains range from 0 to 100 where higher scores are better.
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Timepoint [22]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [23]
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Change From Baseline in Patient Acceptable Symptom State (PASS)
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Assessment method [23]
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The Patient Acceptable Symptom State (PASS) was a participant-completed form in which participants were asked to "Think about all the ways your rheumatoid arthritis (RA) has affected you during the last 48 hours. If you were to remain in the next few months as you were during the last 48 hours, would this be acceptable or unacceptable to you?" The participant indicated a response of either "acceptable" or "unacceptable".
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Timepoint [23]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [24]
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Change From Baseline in Vectra Disease Activity Levels
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Assessment method [24]
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The change from Baseline in Vectra disease activity levels was to be estimated. The assessment measures serum protein biomarkers associated with RA. It has a range from 1-100 with lower scores indicating the better outcome.
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Timepoint [24]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [25]
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Number of Participants With Positive Etanercept Anti-drug Antibody Status
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Assessment method [25]
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Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.
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Timepoint [25]
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Baseline, 12 weeks, 24 weeks
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Secondary outcome [26]
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Number of Participants With Positive Etanercept Neutralizing Anti-drug Antibody Status
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Assessment method [26]
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Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.
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Timepoint [26]
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Baseline, 12 weeks, 24 weeks
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Eligibility
Key inclusion criteria
1. Met the 1987 ACR Revised Criteria for RA
2. A history of inadequate response to infliximab or adalimumab in combination with
methotrexate.
3. A stable dose of oral methotrexate for at least 6 weeks before the baseline visit.
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Minimum age
18
Years
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Maximum age
79
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. ACR functional class IV
2. Prior treatment with etanercept; both infliximab and adalimumab; or any
immunosuppressive biologic agent other than infliximab or adalimumab.
3. Discontinuation of infliximab or adalimumab for a primary reason other than inadequate
efficacy response.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2014
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Sample size
Target
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Accrual to date
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Final
16
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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RK Will Pty Ltd - Victoria Park
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Recruitment postcode(s) [1]
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6100 - Victoria Park
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Bruxelles
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Country [2]
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France
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State/province [2]
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Montpellier
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Country [3]
0
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Hong Kong
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State/province [3]
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New Territories
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Country [4]
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Hong Kong
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State/province [4]
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Tseung Kwan O, NT
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Country [5]
0
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Israel
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State/province [5]
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Haifa
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Country [6]
0
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Israel
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State/province [6]
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Kfar Saba
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Country [7]
0
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Russian Federation
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State/province [7]
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Izhevsk
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Country [8]
0
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Russian Federation
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State/province [8]
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Kazan
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Country [9]
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Russian Federation
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State/province [9]
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Moscow
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Country [10]
0
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Spain
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State/province [10]
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0
Barcelona
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Country [11]
0
0
Spain
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State/province [11]
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Málaga
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Country [12]
0
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Spain
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State/province [12]
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Sevilla
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to
placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or
adalimumab plus methotrexate. This comparison will be performed for all subjects and
separately for subjects who are anti-drug antibody positive for one of these medications.
From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect
of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of
etanercept in these subjects will also be evaluated throughout the study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01783015
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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0
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Phone
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Fax
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0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01783015
Download to PDF