Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

NCT02378506 | Completed Phase 3 Results

• 2 other identifiers: B18013592013-004569-16
• Study Type: interventional
• Target: 188
• Locations: 9 countries
• Sites: 31

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.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12

  Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.

  Week 12

• Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24

  Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.

  Week 24

• Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment

  Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.

  Baseline up to Week 24

Secondary Outcomes (11)

• Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment

  Baseline (Day 1) up to Week 24

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline (Day 1) up to Week 28 (Follow-up)

• Number of Participants With Investigator-Identified Serious Infections

  Baseline (Day 1) up to Week 28 (Follow-up)

• Number of Participants With Injection Site Reactions

  Baseline (Day 1) up to Week 28 (Follow-up)

• Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities

  Baseline (Day 1) up to Week 28 (Follow-up)

Study Arms (1)

ETN 50mg QW

EXPERIMENTAL

Biological: etanercept

Interventions

etanercept BIOLOGICAL

50mg subcutaneous, once weekly, 24 weeks

ETN 50mg QW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (31)

MHAT Plovdiv

Plovdiv, 4000, Bulgaria

Location

DCC "Aleksandrovska" EOOD

Sofia, 1431, Bulgaria

Location

UMHAT "Sv. Ivan Rilski" EAD, Sofia

Sofia, 1612, Bulgaria

Location

Medical Center - "New rehabilitation center" EOOD

Stara Zagora, 6000, Bulgaria

Location

Chc Rijeka

Rijeka, 51000, Croatia

Location

Medicinski Centar Kuna Peric

Zagreb, 10000, Croatia

Location

Centrum für innovative Diagnostik und Therapie

Frankfurt am Main, Hesse, 60528, Germany

Location

Rheumaforschung - Studienambulanz Dr. Wassenberg

Ratingen, North Rhine-Westphalia, 40882, Germany

Location

Schlosspark-Klinik, Innere Medizin II, Rheumatologie

Berlin, 14059, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Immunologisches Zentrum Vogelsang-Gommern GmbH

Vogelsang-Gommern, 39245, Germany

Location

Rheumatology Department

Rion Patras, Achaia, 26500, Greece

Location

University Hospital of Heraklion

Heraklion, Crete, 71110, Greece

Location

Rheumatology Unit

Thessaloniki, 56429, Greece

Location

Qualiclinic Kft.

Budapest, 1036, Hungary

Location

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, 2143, Hungary

Location

Szabolcs-Szatmar-Bereg megyei

Nyíregyháza, 4400, Hungary

Location

Krakowskie Centrum Medyczne sp. Z.O.O

Krakow, 31-501, Poland

Location

NZOZ Lecznica MAK-MED s.c.

Nadarzyn, 05-830, Poland

Location

Prywatna Praktyka Lekarska Prof. UM dr hab.med. Pawel Hrycaj

Poznan, 61-397, Poland

Location

Reumatika-Centrum Reumatologii

Warsaw, 02-691, Poland

Location

Institute of Rheumatology

Belgrade, Beograd, 11000, Serbia

Location

Reumatologicka ambulancia

Bratislava, 841 04, Slovakia

Location

AAGS, s.r.o.

Dunajská Streda, 929 01, Slovakia

Location

Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o.

Poprad, 058 01, Slovakia

Location

REUMEX s.r.o.

Rimavská Sobota, 979 01, Slovakia

Location

REUMA-GLOBAL s.r.o.

Trnava, 917 01, Slovakia

Location

Reumatologicka ambulancia

Žilina, 010 01, Slovakia

Location

Panorama Medical Centre

Panorama, Cape Town, 7500, South Africa

Location

Wits Clinical Research CMJAH Clinical Trial Site

Parktown, Johannesburg, 2193, South Africa

Location

St. Augustines Hospital

Durban/Berea, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (1)

• 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.

  PMID: 30451655 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: March 4, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-03

Locations

HU (3); GR (3); DE (5); PL (4); SE (1); SL (6); CR (2); ZA (3); BU (4)