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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
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

NCT03001219

TerminatedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Rheumatoid Arthritis

Interventions: Anti-TNF-alpha, Methotrexate, Placebo, RO7123520

Countries: United States, Argentina, Austria, Colombia, Germany, Guatemala, Italy, Mexico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 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:

* 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
Locations (81)
  • Anniston, Alabama, United States
  • Glendale, Arizona, United States
  • Mesa, Arizona, United States
  • Phoenix, Arizona, United States
  • Covina, California, United States
  • La Jolla, California, United States
  • Lakewood, California, United States
  • Stanford, California, United States
  • DeBary, Florida, United States
  • Hialeah, Florida, United States
  • Ormond Beach, Florida, United States
  • Worcester, Massachusetts, United States
  • Saint Clair Shores, Michigan, United States
  • Freehold, New Jersey, United States
  • Toms River, New Jersey, United States
  • Toms River, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • Albuquerque, New Mexico, United States
  • Canton, New York, United States
  • Middleburg Heights, Ohio, United States
  • Duncansville, Pennsylvania, United States
  • Wexford, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Columbia, South Carolina, United States
  • Jackson, Tennessee, United States
  • Corpus Christi, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • + 51 more on CT.gov