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
Status and phase
Terminated
Phase 2
Conditions
Rheumatoid Arthritis
Treatments
Drug: Methotrexate
Drug: RO7123520
Drug: Placebo
Drug: Anti-TNF-alpha
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
109 patients
Sex
All
Ages
18+ years old
Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
109 participants in 6 patient groups, including a placebo group
Part 1: Placebo
Placebo Comparator group
Description:
Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
Treatment:
Drug: Placebo
Drug: Anti-TNF-alpha
Drug: Methotrexate
Part 1: RO7123520
Experimental group
Description:
Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
Treatment:
Drug: RO7123520
Drug: Anti-TNF-alpha
Drug: Methotrexate
Part 2: Placebo
Placebo Comparator group
Description:
Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
Treatment:
Drug: Placebo
Drug: Anti-TNF-alpha
Drug: Methotrexate
Part 2: RO7123520
Experimental group
Description:
Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
Treatment:
Drug: RO7123520
Drug: Anti-TNF-alpha
Drug: Methotrexate
Part 3: Placebo
Placebo Comparator group
Description:
Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
NOTE: Part 3 was not conducted.
Treatment:
Drug: Placebo
Drug: Anti-TNF-alpha
Drug: Methotrexate
Part 3: RO7123520
Experimental group
Description:
Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.
NOTE: Part 3 was not conducted.
Treatment:
Drug: RO7123520
Drug: Anti-TNF-alpha
Drug: Methotrexate
Trial contacts and locations
81
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Data sourced from clinicaltrials.gov
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