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A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: PF-06410293 (Biological); Adalimumab (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Summary

The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate.

Clinical Details

Official title: A Phase 3, Randomized, Double-blind Study Comparing The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of Pf-06410293 And Adalimumab In Subjects With Moderate To Severe, Active Rheumatoid Arthritis On A Background Of Methotrexate

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Participants With an American College of Rheumatology 20% (ACR20) Response

Secondary outcome:

Number of Participants With an American College of Rheumatology 20% (ACR20) Response

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

Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response

Disease Activity Score Based on 28-joints Count (DAS28)-4(CRP)

DAS Remission (≤2.6)

EULAR Response and ACR / EULAR Remission

Change from baseline in individual components of ACR response

Incidence and titers of anti-drug antibodies (ADA) and neutralizing antibodies (Nab)

Serum drug concentration

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4

months.

- At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening

and baseline.

- Hs-CRP equal or greater than 8 mg/L.

- Must have received methotrexate for at least 12 weeks and been on a stable dose for

at least 4 weeks prior to the first study dose. Exclusion Criteria:

- Evidence of untreated or inadequately treated latent or active TB.

- Evidence of uncontrolled, clinically significant diseases, including moderate or

severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.

- History of infection requiring hospitalization or parenteral antimicrobial therapy

within 6 months prior to first dose of study drug.

- May have received no more than 2 doses of one biologic therapy (other than adalimumab

or lymphocyte depleting therapy).

- Any second DMARD must be washed out prior to the first study dose.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Revmatologie Bruntal, s.r.o., Bruntal 792 01, Czech Republic; Recruiting

Schlosspark-Klinik, Berlin 14059, Germany; Recruiting

Schwerpunktpraxis für Rheumatologie und Klinische Immunologie an den Kreiskliniken, Burghausen 84489, Germany; Recruiting

Praxiszentrum St. Bonifatius, München 81541, Germany; Recruiting

Rheumapraxis Dr. Martin Welcker und Kollegen, Planegg 82152, Germany; Recruiting

Knappschaftsklinikum Saar GmbH, Püttlingen 66346, Germany; Recruiting

Qualiclinic Kft., Budapest 1036, Hungary; Recruiting

Dong-A University Hospital, Busan 602-715, Korea, Republic of; Recruiting

Chonnam National University Hospital, Gwangju 501-757, Korea, Republic of; Recruiting

Severance Hospital, Yonsei University Health System, Seoul 120-752, Korea, Republic of; Recruiting

LSMUL Kauno klinikos, Kaunas LT-50009, Lithuania; Recruiting

Hospital Universitario Reina Sofía, Córdoba 14004, Spain; Recruiting

Hospital Universitario Ramón y Cajal, Madrid 28034, Spain; Recruiting

Hospital Infanta Luisa, Sevilla 41010, Spain; Recruiting

Komunalna 4-a miska klinichna likarnia m. Lvova,, m. Lviv 79011, Ukraine; Recruiting

Arthrocare, Arthritis Care & Research PC, Gilbert, Arizona 85234, United States; Recruiting

Westlake Medical Research, Thousand Oaks, California 91360, United States; Recruiting

Javed Rheumatology Associates Inc, Newark, Delaware 19713, United States; Recruiting

Greenacres Hospital, Port Elizabeth, Eastern Cape, South Africa 6045, South Africa; Recruiting

Alastair C. Kennedy, MD, Vero Beach, Florida 32960, United States; Recruiting

Clinresco Centres (Pty) Ltd, Kempton Park, Gauteng, South Africa 1619, South Africa; Recruiting

Charlotte Maxeke Johannesburg Academic Hospital, Parktown/Johannesburg, Gauteng/South Africa 2193, South Africa; Recruiting

Debreceni Egyetem Klinikai Központ, Debrecen, Hajdú-Bihar H-4032, Hungary; Recruiting

Physician's Clinic of Iowa, P.C., Cedar Rapids, Iowa 52403, United States; Recruiting

Graves-Gilbert Clinic Bowling Green, Bowling Green, Kentucky 42101, United States; Recruiting

Seoul National University Hosptial, Seoul, Korea 110-744, Korea, Republic of; Recruiting

Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid 28942, Spain; Recruiting

The Center for Rheumatology and Bone Research, Wheaton, Maryland 20902, United States; Recruiting

Physician Research Collaboration, LLC, Lincoln, Nebraska 68516, United States; Recruiting

Manhattan Medical Research, New York, New York 10016, United States; Recruiting

Buffalo Rheumatology and Medicine PLLC, Orchard Park, New York 14127, United States; Recruiting

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States; Recruiting

Clinical Research Center of Reading, LLC, Wyomissing, Pennsylvania 19610, United States; Recruiting

Low Country Rheumatology, PA, Charleston, South Carolina 29406, United States; Recruiting

West Tennessee Research Institute, Jackson, Tennessee 38305, United States; Recruiting

Ramesh C Gupta, M.D., Memphis, Tennessee 38119, United States; Recruiting

Amarillo Center for Clinical Research, Amarillo, Texas 79124, United States; Recruiting

Austin Regional Clinic, Austin, Texas 78731, United States; Recruiting

The Clinical Research Institute of Houston, LLC, Houston, Texas 77090, United States; Recruiting

Southwest Rheumatology Research, LLC, Mesquite, Texas 75150, United States; Recruiting

Northwest Diagnostic Clinic, PA, Shenandoah, Texas 77380, United States; Recruiting

Center for Arthritis and Rheumatic Diseases, P.C., Chesapeake, Virginia 23320, United States; Recruiting

Center for Arthritis and Rheumatic Diseases, P.C., Suffolk, Virginia 23435, United States; Recruiting

Hospital Universitario Cruces, Barakaldo, Vizcaya 48903, Spain; Recruiting

Wenatchee Valley Hospitals & Clinics, Wenatchee, Washington 98801, United States; Recruiting

Rheumatology and Pulmonary Clinic, Beckley, West Virginia 25801, United States; Recruiting

Arthritis Clinical Research Trials, Dr CE Spargo and Dr RB Bhorat Practice, Cape Town, Western Cape, South Africa 7405, South Africa; Recruiting

Panorama Medical Centre, Cape Town, Western Cape, South Africa 7500, South Africa; Recruiting

Additional Information

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

Starting date: July 2015
Last updated: August 4, 2015

Page last updated: August 23, 2015

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