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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2012-003644-71
Secondary ID [2] 0 0
B1801355
Universal Trial Number (UTN)
Trial acronym
SERUM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the Disease Activity Score Based on a 28 Joint Count (DAS28-C-reactive Protein [CRP]) at Week 12.
Timepoint [1] 0 0
Baseline, 12 weeks
Secondary outcome [1] 0 0
Change From Baseline in the DAS28 at Week 24
Timepoint [1] 0 0
Baseline, 24 weeks
Secondary outcome [2] 0 0
Number of Participants With DAS28 <3.2
Timepoint [2] 0 0
12 weeks, 24 weeks
Secondary outcome [3] 0 0
Number of Participants With DAS28 <2.6
Timepoint [3] 0 0
12 weeks, 24 weeks
Secondary outcome [4] 0 0
Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Timepoint [4] 0 0
12 weeks, 24 weeks
Secondary outcome [5] 0 0
Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Timepoint [5] 0 0
12 weeks, 24 weeks
Secondary outcome [6] 0 0
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Timepoint [6] 0 0
12 weeks, 24 weeks
Secondary outcome [7] 0 0
Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response
Timepoint [7] 0 0
12 weeks, 24 weeks
Secondary outcome [8] 0 0
Number of Participants Achieving European League Against Rheumatism (EULAR) Good and/or Moderate Response.
Timepoint [8] 0 0
12 weeks, 24 weeks
Secondary outcome [9] 0 0
Number of Participants Achieving Low Disease Activity or Remission Based on Clinical Disease Activity Index (CDAI)
Timepoint [9] 0 0
12 weeks, 24 weeks
Secondary outcome [10] 0 0
Number of Participants Achieving Low Disease Activity or Remission Based on Simplified Disease Activity Index (SDAI).
Timepoint [10] 0 0
12 weeks, 24 weeks
Secondary outcome [11] 0 0
Change From Baseline in CDAI
Timepoint [11] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [12] 0 0
Change From Baseline in SDAI.
Timepoint [12] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [13] 0 0
Change From Baseline in Number of Tender/Painful Joints
Timepoint [13] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [14] 0 0
Change From Baseline in Number of Swollen Joints
Timepoint [14] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [15] 0 0
Change From Baseline in Physician Global Assessment of Disease Activity
Timepoint [15] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [16] 0 0
Change From Baseline in Subject Global Assessment of Disease Activity
Timepoint [16] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [17] 0 0
Change From Baseline in Subject General Health VAS.
Timepoint [17] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [18] 0 0
Change From Baseline in Subject Pain
Timepoint [18] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [19] 0 0
Change From Baseline in CRP
Timepoint [19] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [20] 0 0
Change From Baseline in Health Assessment Questionnaire Disability and Discomfort Scales (HAQ-DI)
Timepoint [20] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [21] 0 0
Change From Baseline in Euro Quality of Life (Qol) EQ-5 Dimensions Questionnaire (EQ-5D)
Timepoint [21] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [22] 0 0
Change From Baseline in Short Form-36 Health Survey (SF-36)
Timepoint [22] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [23] 0 0
Change From Baseline in Patient Acceptable Symptom State (PASS)
Timepoint [23] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [24] 0 0
Change From Baseline in Vectra Disease Activity Levels
Timepoint [24] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [25] 0 0
Number of Participants With Positive Etanercept Anti-drug Antibody Status
Timepoint [25] 0 0
Baseline, 12 weeks, 24 weeks
Secondary outcome [26] 0 0
Number of Participants With Positive Etanercept Neutralizing Anti-drug Antibody Status
Timepoint [26] 0 0
Baseline, 12 weeks, 24 weeks

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.
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
RK Will Pty Ltd - Victoria Park
Recruitment postcode(s) [1] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
France
State/province [2] 0 0
Montpellier
Country [3] 0 0
Hong Kong
State/province [3] 0 0
New Territories
Country [4] 0 0
Hong Kong
State/province [4] 0 0
Tseung Kwan O, NT
Country [5] 0 0
Israel
State/province [5] 0 0
Haifa
Country [6] 0 0
Israel
State/province [6] 0 0
Kfar Saba
Country [7] 0 0
Russian Federation
State/province [7] 0 0
Izhevsk
Country [8] 0 0
Russian Federation
State/province [8] 0 0
Kazan
Country [9] 0 0
Russian Federation
State/province [9] 0 0
Moscow
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Málaga
Country [12] 0 0
Spain
State/province [12] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01783015
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01783015