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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02720120
Other study ID # WA18230
Secondary ID 2004-002132-26
Status Terminated
Phase Phase 1/Phase 2
First received March 22, 2016
Last updated March 25, 2016
Start date October 2005
Est. completion date February 2013

Study information

Verified date March 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 175
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Moderate to severe RA for at least 6 months

- Positive serum rheumatoid factor (>/= 20 international units per milliliter)

- Current treatment with RA on an outpatient basis

- Treatment failure with one disease modifying anti-rheumatic drug (DMARD) or biologic, but have not failed more than six of these agents including methotrexate

- Current treatment with methotrexate for at least 12 weeks, at a stable dose

- Use of highly effective contraception.

Exclusion Criteria:

- Rheumatic autoimmune disease or inflammatory joint disease, other than RA

- Concurrent treatment with any disease-modifying anti-rheumatic drug (DMARD) (other than methotrexate) or any anti-tumor necrosis factor (TNF) -alfa or other biologic therapy

- Treatment with any other investigational drug within 4 weeks of screening

- Previous treatment with cell-depleting therapies, IV gamma-globulin, intra-articular or parenteral corticosteroids, and receipt of live/attenuated vaccine prior to screening

- Previous treatment with rituximab or any other anti-cluster of differentiation 20 (CD20) agent

- History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies

- Known active bacterial, viral or fungal infections

- History of active tuberculosis and primary or secondary immunodeficiency

- History of concomitant diseases such as cardiovascular disease, nervous system, pulmonary disease, renal, hepatic, endocrine or gastrointestinal disorders

- Pregnancy or lactation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ocrelizumab
Participants will receive single IV infusion of ocrelizumab at 400, 1000, 1500, and 2000 mg.
Placebo
Participants will receive single IV infusion of placebo.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  Netherlands,  New Zealand,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Adverse Events (AEs) or Serious AEs (SAEs) Baseline up to approximately 7.25 years No
Primary Percentage of Participants with Anti-Ocrelizumab Antibodies Baseline up to approximately 7.25 years No
Secondary Percentage of Participants with American College of Rheumatology (ACR) 20%, 50%, and 70% (ACR20/50/70) Response at Week 24 Week 24 No
Secondary Disease Activity Score at Week 24 Week 24 No
Secondary Percentage of Participants achieving European League Against Rheumatism (EULAR) Response at Week 24 Week 24 No
Secondary Maximum Plasma Concentration (Cmax) of Ocrelizumab Pre-infusion (0 hours); 30 minutes post infusion on Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 (up to Week 24), and Weeks 36, 48 (Post Week 24) No
Secondary Time to Blood B-Cell Depletion Baseline up to approximately 7.25 years No
Secondary Terminal Elimination Half-Life (t1/2) of Ocrelizumab Pre-infusion (0 hours); 30 minutes post infusion on Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 (up to Week 24), and Weeks 36, 48 (Post Week 24) No
Secondary Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity AUC(0-inf) of Ocrelizumab Pre-infusion (0 hours); 30 minutes post infusion on Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 (up to Week 24), and Weeks 36, 48 (Post Week 24) No
Secondary Area Under the Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Concentration AUC(0-last) of Ocrelizumab Pre-infusion (0 hours); 30 minutes post infusion on Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 (up to Week 24), and Weeks 36, 48 (Post Week 24) No
Secondary Time to Maximum Observed Plasma Concentration (Tmax) of Ocrelizumab Pre-infusion (0 hours); 30 minutes post infusion on Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 (up to Week 24), and Weeks 36, 48 (Post Week 24) No
Secondary Terminal Rate Constant of Ocrelizumab Pre-infusion (0 hours); 30 minutes post infusion on Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 (up to Week 24), and Weeks 36, 48 (Post Week 24) No
Secondary Systemic Clearance (CL) of Ocrelizumab Pre-infusion (0 hours); 30 minutes post infusion on Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 (up to Week 24), and Weeks 36, 48 (Post Week 24) No
Secondary Mean Residence Time (MRT) of Ocrelizumab Pre-infusion (0 hours); 30 minutes post infusion on Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 (up to Week 24), and Weeks 36, 48 (Post Week 24) No
Secondary Steady State Volume of Distribution (Vss) of Ocrelizumab Pre-infusion (0 hours); 30 minutes post infusion on Day 1; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24 (up to Week 24), and Weeks 36, 48 (Post Week 24) No
Secondary Duration of Blood B-Cell Depletion Baseline up to approximately 7.25 years No
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