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Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate (SERUM)

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ClinicalTrials.gov Identifier: NCT01783015
Recruitment Status : Terminated (This study was prematurely terminated on June 25, 2014 due to lack of enrollment.)
First Posted : February 4, 2013
Results First Posted : January 6, 2016
Last Update Posted : January 6, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Etanercept
Drug: Placebo
Enrollment 16
Recruitment Details In this 24 week, multicenter, randomized, double-blind, placebo-controlled (Period 1), 2 period study, a total of 20 participants were screened, out of which 16 participants were randomized. Due to delayed enrollment and an insufficient number of participants, recruitment was terminated.
Pre-assignment Details Eleven participants were randomly assigned to etanercept [ETN] and 5 participants to placebo in the blinded treatment period. A total of 11 participants (9 ETN treated and 2 placebo treated) completed the blinded treatment period and entered the open label treatment with ETN. One of the 2 placebo treated participants entered the Escape Arm.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly. Participants received placebo injections with oral methotrexate tablets once-weekly. Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Period Title: Blinded Treatment
Started 11 5 0
Treated 11 5 0
Completed 9 2 0
Not Completed 2 3 0
Reason Not Completed
Adverse Event             0             1             0
Protocol Violation             0             1             0
Withdrawal by Subject             0             1             0
Study Terminated by Sponsor             2             0             0
Period Title: Open Label Treatment
Started 0 0 11
Completed 0 0 5
Not Completed 0 0 6
Reason Not Completed
Study Terminated by Sponsor             0             0             6
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Total
Hide Arm/Group Description Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly. Participants received placebo injections with oral methotrexate tablets once-weekly. Total of all reporting groups
Overall Number of Baseline Participants 11 5 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 5 participants 16 participants
54.5  (13.43) 54.8  (19.56) 54.6  (14.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 5 participants 16 participants
Female
8
  72.7%
4
  80.0%
12
  75.0%
Male
3
  27.3%
1
  20.0%
4
  25.0%
1.Primary Outcome
Title Change From Baseline in the Disease Activity Score Based on a 28 Joint Count (DAS28-C-reactive Protein [CRP]) at Week 12.
Hide Description 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).
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline in the DAS28 at Week 24
Hide Description 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).
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With DAS28 <3.2
Hide Description Number of participants with DAS28 <3.2. A score of < 3.2 implied low disease activity.
Time Frame 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Participants With DAS28 <2.6
Hide Description Number of Participants with DAS28 <2.6. A DAS28 < 2.6 implies remission.
Time Frame 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Hide Description 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.
Time Frame 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Hide Description 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.
Time Frame 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Hide Description 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.
Time Frame 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response
Hide Description 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.
Time Frame 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Participants Achieving European League Against Rheumatism (EULAR) Good and/or Moderate Response.
Hide Description 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.
Time Frame 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Number of Participants Achieving Low Disease Activity or Remission Based on Clinical Disease Activity Index (CDAI)
Hide Description 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.
Time Frame 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Number of Participants Achieving Low Disease Activity or Remission Based on Simplified Disease Activity Index (SDAI).
Hide Description 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.
Time Frame 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Change From Baseline in CDAI
Hide Description 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.
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Change From Baseline in SDAI.
Hide Description 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.
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Change From Baseline in Number of Tender/Painful Joints
Hide Description 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.
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Change From Baseline in Number of Swollen Joints
Hide Description Change from Baseline in the number of swollen joints including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Change From Baseline in Physician Global Assessment of Disease Activity
Hide Description 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).
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Change From Baseline in Subject Global Assessment of Disease Activity
Hide Description 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).
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Change From Baseline in Subject General Health VAS.
Hide Description Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Change From Baseline in Subject Pain
Hide Description 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.
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Change From Baseline in CRP
Hide Description 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.
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire Disability and Discomfort Scales (HAQ-DI)
Hide Description 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.
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Change From Baseline in Euro Quality of Life (Qol) EQ-5 Dimensions Questionnaire (EQ-5D)
Hide Description 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.
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Change From Baseline in Short Form-36 Health Survey (SF-36)
Hide Description 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.
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
24.Secondary Outcome
Title Change From Baseline in Patient Acceptable Symptom State (PASS)
Hide Description 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".
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title Change From Baseline in Vectra Disease Activity Levels
Hide Description 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.
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Vectra disease activity analysis of laboratory samples was not conducted due to study termination.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title Number of Participants With Positive Etanercept Anti-drug Antibody Status
Hide Description 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.
Time Frame Baseline, 12 weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title Number of Participants With Positive Etanercept Neutralizing Anti-drug Antibody Status
Hide Description 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.
Time Frame Baseline, 12 weeks, 24 weeks
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Hide Analysis Population Description
Due to small sample size, Pfizer did not perform statistical analysis.
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description:
Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
Participants received placebo injections with oral methotrexate tablets once-weekly.
Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From the day the first dose of the investigational product was administered up to 28 days after last dose was administered.
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Hide Arm/Group Description Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly. Participants received placebo injections with oral methotrexate tablets once-weekly. Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
All-Cause Mortality
Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/5 (0.00%)   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Period I - Blinded Treatment - Etanercept Period I - Blinded Treatment - Placebo Period 2 - Open Label Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/11 (45.45%)   3/5 (60.00%)   4/11 (36.36%) 
Blood and lymphatic system disorders       
ANAEMIA * 1  0/11 (0.00%)  1/5 (20.00%)  0/11 (0.00%) 
Ear and labyrinth disorders       
TINNITUS * 1  0/11 (0.00%)  1/5 (20.00%)  0/11 (0.00%) 
Gastrointestinal disorders       
DYSPEPSIA * 1  0/11 (0.00%)  1/5 (20.00%)  0/11 (0.00%) 
GASTROINTESTINAL DISORDER * 1  1/11 (9.09%)  0/5 (0.00%)  0/11 (0.00%) 
NAUSEA * 1  0/11 (0.00%)  1/5 (20.00%)  0/11 (0.00%) 
General disorders       
INJECTION SITE ERYTHEMA * 1  1/11 (9.09%)  0/5 (0.00%)  1/11 (9.09%) 
INJECTION SITE REACTION * 1  1/11 (9.09%)  0/5 (0.00%)  0/11 (0.00%) 
Infections and infestations       
NASOPHARYNGITIS * 1  1/11 (9.09%)  0/5 (0.00%)  0/11 (0.00%) 
RHINITIS * 1  0/11 (0.00%)  1/5 (20.00%)  1/11 (9.09%) 
TONSILLITIS * 1  1/11 (9.09%)  0/5 (0.00%)  1/11 (9.09%) 
TOOTH INFECTION * 1  0/11 (0.00%)  0/5 (0.00%)  1/11 (9.09%) 
URINARY TRACT INFECTION * 1  1/11 (9.09%)  0/5 (0.00%)  0/11 (0.00%) 
Musculoskeletal and connective tissue disorders       
TENDONITIS * 1  0/11 (0.00%)  0/5 (0.00%)  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders       
RHINORRHOEA * 1  2/11 (18.18%)  0/5 (0.00%)  0/11 (0.00%) 
Skin and subcutaneous tissue disorders       
DERMATITIS * 1  0/11 (0.00%)  1/5 (20.00%)  0/11 (0.00%) 
Vascular disorders       
HYPERTENSION * 1  0/11 (0.00%)  0/5 (0.00%)  1/11 (9.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 17.1
This study was prematurely terminated on June 25, 2014. This termination was due to delays in achieving the enrolment target and not due to any safety concerns. No statistical analyses were done since there were a small number of participants.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01783015    
Other Study ID Numbers: B1801355
2012-003644-71 ( EudraCT Number )
First Submitted: January 31, 2013
First Posted: February 4, 2013
Results First Submitted: May 12, 2015
Results First Posted: January 6, 2016
Last Update Posted: January 6, 2016