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Monoclonal Antibodies

Part 1: Ocrelizumab 1000 mg for Rheumatoid Arthritis

Phase 1 & 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved

Summary

This study is in two parts and will evaluate the safety, tolerability and efficacy of escalating single intravenous (IV) doses of ocrelizumab compared with placebo in combination with methotrexate in participants with moderate to severe RA. Part 1 is the dose-escalation study, at one of the following dose levels of ocrelizumab \[400, 1000, 1500, and 2000 milligrams (mg)\]. In Part 2, participants will be randomized to explore tolerability and efficacy of doses which have been shown to be tolerated in Part 1.

Eligible Conditions
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: Ocrelizumab 400 mgExperimental Treatment1 Intervention
Participants will receive single IV infusion of ocrelizumab 400 mg.
Group II: Part 2: Ocrelizumab 1500 mgExperimental Treatment1 Intervention
Participants will receive single IV infusion of ocrelizumab 1500 mg.
Group III: Part 2: Ocrelizumab 1000 mgExperimental Treatment1 Intervention
Participants will receive single IV infusion of ocrelizumab 1000 mg.
Group IV: Part 1: Ocrelizumab 400 mgExperimental Treatment1 Intervention
Participants will receive single IV infusion of ocrelizumab 400 milligrams (mg)
Group V: Part 1: Ocrelizumab 2000 mgExperimental Treatment1 Intervention
Participants will receive single IV infusion of ocrelizumab 2000 mg.
Group VI: Part 1: Ocrelizumab 1500 mgExperimental Treatment1 Intervention
Participants will receive single IV infusion of ocrelizumab 1500 mg.
Group VII: Part 1: Ocrelizumab 1000 mgExperimental Treatment1 Intervention
Participants will receive single IV infusion of ocrelizumab 1000 mg.
Group VIII: Part 1: PlaceboPlacebo Group1 Intervention
Participants will receive single IV infusion of placebo matched to ocrelizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ocrelizumab
FDA approved

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,450 Previous Clinical Trials
1,095,308 Total Patients Enrolled
187 Trials studying Rheumatoid Arthritis
106,109 Patients Enrolled for Rheumatoid Arthritis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,220 Previous Clinical Trials
895,215 Total Patients Enrolled
186 Trials studying Rheumatoid Arthritis
107,081 Patients Enrolled for Rheumatoid Arthritis
~9 spots leftby Oct 2025
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