Clinical trial NCT01783015: Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
etanercept
methotrexate
infliximab
adalimumab
anti-drug antibody
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study was prematurely terminated on June 25, 2014 due to significant and continuing delays in achieving the study B1801355 enrolment target. The decision to stop the study was not driven by any safety concerns.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Change From Baseline in the Disease Activity Score Based on a 28 Joint Count (DAS28-C-reactive Protein [CRP]) at Week 12.
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change From Baseline in the DAS28 at Week 24
timeFrame: Baseline, 24 weeks
measure: Number of Participants With DAS28 <3.2
timeFrame: 12 weeks, 24 weeks
measure: Number of Participants With DAS28 <2.6
timeFrame: 12 weeks, 24 weeks
measure: Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response
timeFrame: 12 weeks, 24 weeks
measure: Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
timeFrame: 12 weeks, 24 weeks
measure: Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
timeFrame: 12 weeks, 24 weeks
measure: Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response
timeFrame: 12 weeks, 24 weeks
measure: Number of Participants Achieving European League Against Rheumatism (EULAR) Good and/or Moderate Response.
timeFrame: 12 weeks, 24 weeks
measure: Number of Participants Achieving Low Disease Activity or Remission Based on Clinical Disease Activity Index (CDAI)
timeFrame: 12 weeks, 24 weeks
measure: Number of Participants Achieving Low Disease Activity or Remission Based on Simplified Disease Activity Index (SDAI).
timeFrame: 12 weeks, 24 weeks
measure: Change From Baseline in CDAI
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change From Baseline in SDAI.
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change From Baseline in Number of Tender/Painful Joints
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change From Baseline in Number of Swollen Joints
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change From Baseline in Physician Global Assessment of Disease Activity
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change From Baseline in Subject Global Assessment of Disease Activity
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change From Baseline in Subject General Health VAS.
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change From Baseline in Subject Pain
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change From Baseline in CRP
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change From Baseline in Health Assessment Questionnaire Disability and Discomfort Scales (HAQ-DI)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change From Baseline in Euro Quality of Life (Qol) EQ-5 Dimensions Questionnaire (EQ-5D)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change From Baseline in Short Form-36 Health Survey (SF-36)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change From Baseline in Patient Acceptable Symptom State (PASS)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change From Baseline in Vectra Disease Activity Levels
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Number of Participants With Positive Etanercept Anti-drug Antibody Status
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Number of Participants With Positive Etanercept Neutralizing Anti-drug Antibody Status
timeFrame: Baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Victoria Park
country: Australia
facility: RK Will Pty Ltd
state: Western Australia
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc / Service de Rhumatologie
city: Montpellier
country: France
facility: Hopital Lapeyronie
city: Tseung Kwan O
country: Hong Kong
facility: Tseung Kwan O Hospital
state: New Territories
city: Tseung Kwan O, NT
country: Hong Kong
facility: Tseung Kwan O Hospital
city: Haifa
country: Israel
facility: Bnai Zion Medical Ctr Pharmacy
city: Kfar Saba
country: Israel
facility: Meir Medical Center pharmacy
city: Izhevsk
country: Russian Federation
facility: LLC "Alliance Biomedical - Russian Group"
city: Kazan
country: Russian Federation
facility: LLC Research Medical Complex "Your Health" based on City Clinical Hospital #7
city: Moscow
country: Russian Federation
facility: Scientific Institute of Rheumatology of Russian Academy of Medical Science
city: Moscow
country: Russian Federation
facility: GBOU VPO Moscow State University of Medicine and Dentistry
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i San Pau
city: Málaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya. Hospital Civil
city: Málaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya.
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: