Clinical trial NCT02378506: Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects
Official title: A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-03-04
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints.
* Either the patient or a designee must be capable of administering the subcutaneous injection of study drug.

Exclusion Criteria:

* Prior treatment with etanercept.
* Presence of active infection or active or untreated tuberculosis.

Primary outcomes:
measure: Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment
timeFrame: Baseline up to Week 24
Secondary outcomes:
measure: Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment
timeFrame: Baseline (Day 1) up to Week 24
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline (Day 1) up to Week 28 (Follow-up)
measure: Number of Participants With Investigator-Identified Serious Infections
timeFrame: Baseline (Day 1) up to Week 28 (Follow-up)
measure: Number of Participants With Injection Site Reactions
timeFrame: Baseline (Day 1) up to Week 28 (Follow-up)
measure: Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities
timeFrame: Baseline (Day 1) up to Week 28 (Follow-up)
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
timeFrame: Week 4, 12, 24
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
timeFrame: Week 4, 12, 24
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
timeFrame: Week 4, 12, 24
measure: Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24
timeFrame: Baseline, Week 4, 12, 24
measure: Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24
timeFrame: Baseline, Week 4, 12, 24
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24
timeFrame: Baseline, Week 4, 12, 24
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: MHAT Plovdiv
city: Sofia
country: Bulgaria
facility: DCC "Aleksandrovska" EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski" EAD, Sofia
city: Stara Zagora
country: Bulgaria
facility: Medical Center - "New rehabilitation center" EOOD
city: Rijeka
country: Croatia
facility: Chc Rijeka
city: Zagreb
country: Croatia
facility: Medicinski Centar Kuna Peric
city: Frankfurt/Main
country: Germany
facility: Centrum für innovative Diagnostik und Therapie
state: Hessen
city: Ratingen
country: Germany
facility: Rheumaforschung - Studienambulanz Dr. Wassenberg
state: Nordrhein-westfalen
city: Berlin
country: Germany
facility: Schlosspark-Klinik, Innere Medizin II, Rheumatologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Vogelsang-Gommern
country: Germany
facility: Immunologisches Zentrum Vogelsang-Gommern GmbH
city: Rion Patras
country: Greece
facility: Rheumatology Department
state: Achaia
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
state: Crete
city: Thessaloniki
country: Greece
facility: Rheumatology Unit
city: Budapest
country: Hungary
facility: Qualiclinic Kft.
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Korhaz
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg megyei
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne sp. Z.O.O
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED s.c.
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof. UM dr hab.med. Pawel Hrycaj
city: Warszawa
country: Poland
facility: Reumatika-Centrum Reumatologii
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
state: Beograd
city: Bratislava
country: Slovakia
facility: Reumatologicka ambulancia
city: Dunajska Streda
country: Slovakia
facility: AAGS, s.r.o.
city: Poprad
country: Slovakia
facility: Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o.
city: Rimavska Sobota
country: Slovakia
facility: REUMEX s.r.o.
city: Trnava
country: Slovakia
facility: REUMA-GLOBAL s.r.o.
city: Zilina
country: Slovakia
facility: Reumatologicka ambulancia
city: Panorama
country: South Africa
facility: Panorama Medical Centre
state: Cape Town
city: Parktown
country: South Africa
facility: Wits Clinical Research CMJAH Clinical Trial Site
state: Johannesburg
city: Durban/Berea
country: South Africa
facility: St. Augustines Hospital
state: Kwazulu-natal
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Polak P, Peric P, Louw I, Gaylord SM, Williams T, Becker JC, Pedersen R, Korth-Bradley J, Vlahos B. A single-arm, open-label study to assess the immunogenicity, safety, and efficacy of etanercept manufactured using the serum-free, high-capacity manufacturing process administered to patients with rheumatoid arthritis. Eur J Rheumatol. 2019 Jan;6(1):23-28. doi: 10.5152/eurjrheum.2018.18078.