Clinical Trial Details

NCT ID: NCT03001219
Date Last Changed: September 25, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating RO7123520, Placebo, Anti-TNF-alpha and Methotrexate for the treatment of RheumatoId Arthritis

Research Study Title

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha Inhibitors

Purpose

This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the option of continuing to the extension period of the study.

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Hoffmann-La Roche
Duration
21 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 80 Years

Inclusion Criteria:

  • Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 months before screening

  • Moderately to severely active RA as defined by at least 4/28 tender joints and at least 4/28 swollen joints, and a DAS28 greater than or equal to (≥) 3.2

  • For Part 2 only: Active synovitis and/or osteitis of the dominant hand/wrist as determined by contrast-enhanced magnetic resonance imaging

  • Participants must be taking stable dose of anti-TNF-alpha therapies

  • Participants on stable oral glucocorticoids within 6 weeks of planned randomization

  • Participants taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (up to 2-3 times weekly) for short-term relief of pain and participants on regular NSAID use (on stable dose for ≥ 4 weeks)

Exclusion Criteria:

  • Currently receiving concomitant treatment with sulfasalazine, or leflunomide. Note: Enrollment is allowed after an appropriate wash-out period

  • Participants currently on intravenous (IV) infliximab or an approved IV biosimilar of it

  • Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeks or less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study

  • Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6 weeks prior to planned randomization

  • Active inflammatory diseases of the joints not related to RA

  • Systemic autoimmune disease other than RA

  • Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16

  • Active fibromyalgia that makes appropriate assessment of RA disease activity challenging in the opinion of the Investigator

  • RA participants functional status class IV according to the ACR 1991 criteria

  • Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections

  • History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection

  • Any identified confirmed congenital or acquired immunodeficiency

  • Abnormal laboratory values and liver function test

  • Myocardial infarction within less than 6 months prior to participation in the study

  • Severe central or peripheral nervous system diseases

Site Locations (17)

Country State City Zip Facility and Contact
United States Alabama Anniston 36207 Pinnacle Research Group; Llc, Central
United States Arizona Glendale 85306 Arizona Arthritis & Rheumatology Associates, P.C.
United States Arizona Mesa 85202 Arizona Arthritis and Rheuma
United States Arizona Phoenix 85037 Arizona Arthritis & Rheumatology Research, PLLC
United States Florida DeBary 32713-1817 Omega Research Consultants LLC
United States Florida Hialeah 33015-5110 San Marcus Research Clinic, Inc.
United States Michigan Saint Clair Shores 48080 Shores Rheumatology PC
United States New Jersey Freehold Arthritis & Osteoporosis Associates
United States Ohio Middleburg Heights 44130 Paramount Medical Research
United States Pennsylvania Duncansville 16635 Altoona Center For Clinical Research
United States South Carolina Columbia 29204 Columbia Arthritis Center (Partnership Practice)
United States Tennessee Jackson 38305 West Tennessee Research Institute
United States Texas Dallas 75231 Metroplex Clinical Research
United States Texas Houston 77099 Pioneer Research Solutions
United States Texas Mesquite 75150 Southwest Rheumatology
Germany Berlin 10117 Charité Research Organisation GmbH
Peru Lima Lima 41 Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

Contact

Reference Study ID Number: BP39261 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. and Canada)
E-mail:

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.