A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT03001219

Run by

Hoffmann-La Roche

People needed

109

Starts

2016-12-22

Expected to finish

2018-11-06

Last updated by the study team

2020-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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)

You may not qualify if…

• 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

Where it is running

• Arizona Arthritis & Rheumatology Associates, P.C. — Glendale, Arizona, United States
• Arizona Arthritis and Rheuma — Mesa, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona, United States
• Medvin Clinical Research — Covina, California, United States
• University of California San Diego — La Jolla, California, United States
• Advanced Medical Research, LLC — Lakewood, California, United States
• Stanford hospital & Clinics; Investigational Drug Services — Stanford, California, United States
• Omega Research Consultants LLC — DeBary, Florida, United States
• San Marcus Research Clinic, Inc. — Hialeah, Florida, United States
• Millenium Research — Ormond Beach, Florida, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Shores Rheumatology PC — Saint Clair Shores, Michigan, United States
• Arthritis & Osteoporosis Associates — Freehold, New Jersey, United States
• Atlantic Coast Rheumatology — Toms River, New Jersey, United States
• Ocean Rheumatology — Toms River, New Jersey, United States
• Albuquerque Center For Rheumatology — Albuquerque, New Mexico, United States
• Albuquerque Clinical Trials — Albuquerque, New Mexico, United States
• Saint Lawrence Health System; Rheumatology — Canton, New York, United States
• Paramount Medical Research — Middleburg Heights, Ohio, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• Advanced Rheumatology & Arthritis Research Center — Wexford, Pennsylvania, United States
• Low Country Rheumatology, PA — Charleston, South Carolina, United States
• Columbia Arthritis Center (Partnership Practice) — Columbia, South Carolina, United States
• West Tennessee Research Institute — Jackson, Tennessee, United States
• Pinnacle Research Group; Llc, Central — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.