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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
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Beendet
Diese Studie läuft in
Stadt
- Berlin
Studien-ID:
NCT03001219 2016-002126-36 BP39261
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
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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