Eine Studie zu RO7123520 zur Beurteilung der Sicherheit und Wirksamkeit bei Teilnehmenden mit mäßiger bis schwerer aktiver rheumatoider Arthritis (RA), die unzureichend auf eine Anti-TNF-Alpha-Therapie (TNF: Tumornekrosefaktor) ansprechen

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

  • Autoimmunerkrankung
  • Rheumatoide Arthritis
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Status der Studie:

Beendet

Diese Studie läuft in
Stadt
  • Berlin
Studien-ID:

NCT03001219 2016-002126-36 BP39261

      Studienzentren finden

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.

      Results Disclaimer

      Studienzusammenfassung

      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.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT03001219, BP39261, 2016-002126-36 Studien-ID
      Anti-TNF-alpha, Methotrexate, Placebo, RO7123520 Treatments
      Rheumatoid Arthritis, Rheumatoid Arthritis Condition
      Official 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

      Einschlusskriterien

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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

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