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

NCT01783015 | Terminated Phase 4 Results

• 2 other identifiers: B18013552012-003644-71
• Study Type: interventional
• Target: 16
• Locations: 7 countries
• Sites: 15

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; etanercept; methotrexate; infliximab; adalimumab; anti-drug antibody

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Disease Activity Score Based on a 28 Joint Count (DAS28-C-reactive Protein [CRP]) at Week 12.

  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).

  Baseline, 12 weeks

Secondary Outcomes (26)

• Change From Baseline in the DAS28 at Week 24

  Baseline, 24 weeks

• Number of Participants With DAS28 <3.2

  12 weeks, 24 weeks

• Number of Participants With DAS28 <2.6

  12 weeks, 24 weeks

• Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response

  12 weeks, 24 weeks

• Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response

  12 weeks, 24 weeks

Study Arms (4)

Group A

EXPERIMENTAL

Subjects who are mAb ADA positive

Drug: Etanercept

Group B

EXPERIMENTAL

Subjects who are mAb ADA negative

Drug: Etanercept

Group C

PLACEBO COMPARATOR

Subjects who are mAb ADA positive

Drug: Placebo

Group D

PLACEBO COMPARATOR

Subjects who are mAb ADA negative

Drug: Placebo

Interventions

Etanercept DRUG

Etanercept 50 mg once-weekly

Group A

Placebo DRUG

Etanercept placebo once-weekly

Group C

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Met the 1987 ACR Revised Criteria for RA
• A history of inadequate response to infliximab or adalimumab in combination with methotrexate.
• A stable dose of oral methotrexate for at least 6 weeks before the baseline visit.

You may not qualify if:

• ACR functional class IV
• Prior treatment with etanercept; both infliximab and adalimumab; or any immunosuppressive biologic agent other than infliximab or adalimumab.
• Discontinuation of infliximab or adalimumab for a primary reason other than inadequate efficacy response.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (15)

RK Will Pty Ltd

Victoria Park, Western Australia, 6100, Australia

Location

Cliniques Universitaires Saint-Luc / Service de Rhumatologie

Brussels, 1200, Belgium

Location

Hopital Lapeyronie

Montpellier, 34295 cedex 5, France

Location

Tseung Kwan O Hospital

Tseung Kwan O, New Territories, Hong Kong

Location

Tseung Kwan O Hospital

Tseung Kwan O, NT, Hong Kong

Location

Bnai Zion Medical Ctr Pharmacy

Haifa, 31048, Israel

Location

Meir Medical Center pharmacy

Kfar Saba, 44281, Israel

Location

LLC "Alliance Biomedical - Russian Group"

Izhevsk, Russian Federation, 426063, Russia

Location

LLC Research Medical Complex "Your Health" based on City Clinical Hospital #7

Kazan', 420103, Russia

Location

Scientific Institute of Rheumatology of Russian Academy of Medical Science

Moscow, 115522, Russia

Location

GBOU VPO Moscow State University of Medicine and Dentistry

Moscow, 129301, Russia

Location

Hospital de la Santa Creu i San Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Regional Universitario Carlos Haya. Hospital Civil

Málaga, Málaga, 29009, Spain

Location

Hospital Regional Universitario Carlos Haya.

Málaga, Málaga, 29010, Spain

Location

Hospital Infanta Luisa

Seville, 41010, Spain

Location

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

Limitations and Caveats

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.

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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 4, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 6, 2016
• Results First Posted: January 6, 2016

Record last verified: 2015-12

Locations

BE (1); ES (4); IL (2); FR (1); RU (4); AU (1); HK (2)