Rheumatoid ArthritisPhase 1/2NCT02720120
A Study of Ocrelizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
A Phase 1/2 study testing Ocrelizumab in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 49 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Ocrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 49 sitesin 8 countries
- Study dates
- Oct 2005to Feb 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
49 sites in 8 countries.
49 sites in 8 countries
United Kingdom13 sites
Study site
Aberdeen, AB25 2ZD
Study site
Cambridge, CB2 2QQ
Study site
Derby, DE22 3NE
Study site
Leeds, LS1 3EX
Study site
Liverpool, L9 7AL
Study site
London, E11 1NR
Study site
London, SE1 9RT
Study site
Maidstone, ME16 9QQ
Study site
Newcastle upon Tyne, NE1 4LP
Study site
Norwich, NR4 7UY
Study site
Salford, M6 8HD
Study site
Torquay, TQ2 7AA
Study site
West Midlands, M41 5SL
Spain12 sites
Study site
Alcorcón, Madrid, 28922
Study site
Barcelona, Barcelona, 08025
Study site
Barcelona, Barcelona, 08035
Study site
Cadiz, Cadiz, 11009
Study site
Granada, Granada, 18003
Study site
Madrid, Madrid, 28041
Study site
Madrid, Madrid, 28222
Study site
Madrid, Madrid, 28935
Study site
San Cristóbal de La Laguna, Tenerife, 38320
Study site
Santiago de Compostela, La Coruña, 15706
Study site
Seville, Sevilla, 41014
Study site
Valencia, Valencia, 46017
Canada8 sites
Study site
Calgary, Alberta, T2N 4Z6
Study site
Edmonton, Alberta, T6G 2S2
Study site
London, Ontario, N6A 4V2
Study site
Québec, Quebec, G1V 3M7
Study site
Sherbrooke, Quebec, J1H 5N4
Study site
Toronto, Ontario, M4N 3M5
Study site
Toronto, Ontario, M5G 1X5
Study site
Toronto, Ontario, M5T 2S8
Russia7 sites
Study site
Moscow, 115522
Study site
Moscow, 119049
Study site
Moscow, 129110
Study site
Moscow, 129327
Study site
Saint Petersburg, 190068
Study site
Saint Petersburg, 194291
Study site
Saint Petersburg, 195067
Australia4 sites
Study site
Adelaide, South Australia, 5041
Study site
Darlinghurst, New South Wales, 2010
Study site
Melbourne, Victoria, 3004
Study site
Perth, Western Australia, 6979
About this study
Official title: A Randomized Placebo-Controlled, Multi-Center, Phase I/II Study of the Safety of Escalating Single Intravenous Doses of Ocrelizumab (rhuMAb 2H7, RO4964913, PRO70769) in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate But With Unsatisfactory Clinical Response
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Ocrelizumab, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcrelizumabDrug
Also called RO4964913, rhuMAb 2H7, PRO70769
Participants will receive single IV infusion of ocrelizumab at 400, 1000, 1500, and 2000 mg.
PlaceboDrug
Participants will receive single IV infusion of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Ocrelizumab 1000 mg | Experimental | Participants will receive single IV infusion of ocrelizumab 1000 mg. Receives: Drug: Ocrelizumab |
| Part 1: Ocrelizumab 1500 mg | Experimental | Participants will receive single IV infusion of ocrelizumab 1500 mg. Receives: Drug: Ocrelizumab |
| Part 1: Ocrelizumab 2000 mg | Experimental | Participants will receive single IV infusion of ocrelizumab 2000 mg. Receives: Drug: Ocrelizumab |
| Part 1: Ocrelizumab 400 mg | Experimental | Participants will receive single IV infusion of ocrelizumab 400 milligrams (mg) Receives: Drug: Ocrelizumab |
| Part 1: Placebo | Placebo comparator | Participants will receive single IV infusion of placebo matched to ocrelizumab. Receives: Drug: Placebo |
| Part 2: Ocrelizumab 1000 mg | Experimental | Participants will receive single IV infusion of ocrelizumab 1000 mg. Receives: Drug: Ocrelizumab |
| Part 2: Ocrelizumab 1500 mg | Experimental | Participants will receive single IV infusion of ocrelizumab 1500 mg. Receives: Drug: Ocrelizumab |
| Part 2: Ocrelizumab 400 mg | Experimental | Participants will receive single IV infusion of ocrelizumab 400 mg. Receives: Drug: Ocrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AEs) or Serious AEs (SAEs)
Measured: Baseline up to approximately 7.25 years
Percentage of Participants with Anti-Ocrelizumab Antibodies
Measured: Baseline up to approximately 7.25 years
Secondary outcomes (14)
Percentage of Participants with American College of Rheumatology (ACR) 20%, 50%, and 70% (ACR20/50/70) Response at Week 24
Measured: Week 24
Disease Activity Score at Week 24
Measured: Week 24
Percentage of Participants achieving European League Against Rheumatism (EULAR) Response at Week 24
Measured: Week 24
Maximum Plasma Concentration (Cmax) of Ocrelizumab
Measured: 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)
Time to Blood B-Cell Depletion
Measured: Baseline up to approximately 7.25 years
Terminal Elimination Half-Life (t1/2) of Ocrelizumab
Measured: 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)
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity AUC(0-inf) of Ocrelizumab
Measured: 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)
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Concentration AUC(0-last) of Ocrelizumab
Measured: 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)
Time to Maximum Observed Plasma Concentration (Tmax) of Ocrelizumab
Measured: 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)
Terminal Rate Constant of Ocrelizumab
Measured: 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)
Systemic Clearance (CL) of Ocrelizumab
Measured: 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)
Mean Residence Time (MRT) of Ocrelizumab
Measured: 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)
Steady State Volume of Distribution (Vss) of Ocrelizumab
Measured: 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)
Duration of Blood B-Cell Depletion
Measured: Baseline up to approximately 7.25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startOct 2005
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: The overall benefit risk profile of ocrelizumab was not favorable in RA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720120
- Sponsor's protocol ID
- WA18230
- Other IDs
- 2004-002132-26, 2004
- Status last verified
- Mar 2016
- First submitted
- 22 Mar 2016
- Last updated
- 28 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled, Multi-Center, Phase I/II Study of the Safety of Escalating Single Intravenous Doses of Ocrelizumab (rhuMAb 2H7, RO4964913, PRO70769) in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate But With Unsatisfactory Clinical Response
- ClinicalTrials.gov ID
- NCT02720120
- Acronym / sponsor ID
- WA18230
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The overall benefit risk profile of ocrelizumab was not favorable in RA
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1: Ocrelizumab 1000 mg | Experimental | Drug: OcrelizumabParticipants will receive single IV infusion of ocrelizumab 1000 mg. |
| Part 1: Ocrelizumab 1500 mg | Experimental | Drug: OcrelizumabParticipants will receive single IV infusion of ocrelizumab 1500 mg. |
| Part 1: Ocrelizumab 2000 mg | Experimental | Drug: OcrelizumabParticipants will receive single IV infusion of ocrelizumab 2000 mg. |
| Part 1: Ocrelizumab 400 mg | Experimental | Drug: OcrelizumabParticipants will receive single IV infusion of ocrelizumab 400 milligrams (mg) |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive single IV infusion of placebo matched to ocrelizumab. |
| Part 2: Ocrelizumab 1000 mg | Experimental | Drug: OcrelizumabParticipants will receive single IV infusion of ocrelizumab 1000 mg. |
| Part 2: Ocrelizumab 1500 mg | Experimental | Drug: OcrelizumabParticipants will receive single IV infusion of ocrelizumab 1500 mg. |
| Part 2: Ocrelizumab 400 mg | Experimental | Drug: OcrelizumabParticipants will receive single IV infusion of ocrelizumab 400 mg. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OcrelizumabAlso: RO4964913, rhuMAb 2H7, PRO70769Participants will receive single IV infusion of ocrelizumab at 400, 1000, 1500, and 2000 mg. | Drug | Part 1: Ocrelizumab 1000 mg, Part 1: Ocrelizumab 1500 mg, Part 1: Ocrelizumab 2000 mg, Part 1: Ocrelizumab 400 mg, Part 2: Ocrelizumab 1000 mg, Part 2: Ocrelizumab 1500 mg, Part 2: Ocrelizumab 400 mg |
| PlaceboParticipants will receive single IV infusion of placebo. | Drug | Part 1: Placebo |
Primary outcome
Percentage of Participants with Adverse Events (AEs) or Serious AEs (SAEs)
Time frame: Baseline up to approximately 7.25 years
Percentage of Participants with Anti-Ocrelizumab Antibodies
Time frame: Baseline up to approximately 7.25 years
14 secondary outcomes
Percentage of Participants with American College of Rheumatology (ACR) 20%, 50%, and 70% (ACR20/50/70) Response at Week 24
Time frame: Week 24
Disease Activity Score at Week 24
Time frame: Week 24
Percentage of Participants achieving European League Against Rheumatism (EULAR) Response at Week 24
Time frame: Week 24
Maximum Plasma Concentration (Cmax) of Ocrelizumab
Time frame: 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)
Time to Blood B-Cell Depletion
Time frame: Baseline up to approximately 7.25 years
Terminal Elimination Half-Life (t1/2) of Ocrelizumab
Time frame: 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)
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity AUC(0-inf) of Ocrelizumab
Time frame: 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)
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Quantifiable Concentration AUC(0-last) of Ocrelizumab
Time frame: 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)
Time to Maximum Observed Plasma Concentration (Tmax) of Ocrelizumab
Time frame: 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)
Terminal Rate Constant of Ocrelizumab
Time frame: 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)
Systemic Clearance (CL) of Ocrelizumab
Time frame: 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)
Mean Residence Time (MRT) of Ocrelizumab
Time frame: 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)
Steady State Volume of Distribution (Vss) of Ocrelizumab
Time frame: 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)
Duration of Blood B-Cell Depletion
Time frame: Baseline up to approximately 7.25 years
Results and safety
The study was stopped early (reason given: The overall benefit risk profile of ocrelizumab was not favorable in RA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
49 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ocrelizumab in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 49 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United Kingdom, Spain, Canada, Russia, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The overall benefit risk profile of ocrelizumab was not favorable in RA). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Adverse Events (AEs) or Serious AEs (SAEs) (time frame: Baseline up to approximately 7.25 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2016.