Rheumatoid ArthritisPhase 2NCT00779220
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis
A Phase 2 study testing methotrexate, ocrelizumabu 50mg and ocrelizumabu 200mg in people with Rheumatoid Arthritis, run by Chugai Pharmaceutical at 7 sites in Japan.
Trial summary
This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with methotrexate（MTX）in patients with active rheumatoid arthritis (RA). The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- methotrexate, ocrelizumabu 50mg and ocrelizumabu 200mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 7 sitesJapan
- Study dates
- Oct 2008to Mar 2015
- Phase
- Phase 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of RA for ≧6 months according to the revised 1987 ACR criteria for the classification of RA.
- Adult patients, ≧20 years of age.
- Receiving methotrexate at a dose of 6 to 8mg/week（oral）for ≧12 weeks, with a stable dose for the last 4 weeks before treatment.
- Positive serum RF.
Who cannot join
- Rheumatic autoimmune disease other than RA, or Significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome).Patients with secondary Sjögren's syndrome or secondary limited cutaneous vasculitis with RA are eligible.
- Functional Class Ⅳ as defined by the ACR Classification of Functional Status in RA.
- History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome).
- Any surgical procedure (except for minor surgeries requiring local or no anaesthesia and without any complications or sequelae) within 12 weeks prior to or planned within 24 weeks after baseline.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Chubu region
Chūbu
Chugoku region
Chugoku
Hokkaido Region
Hokkaido
Kanto Region
Kanto
Kinki Region
Kinki
Kyusyu region
Kyusyu
Sikoku region
Sikoku
About this study
Official title: A Randomized, Double-blind, Parallel-group, Study to Evaluate the Efficacy, Safety and PK/PD of Ocrelizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy
This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with methotrexate（MTX）in patients with active rheumatoid arthritis (RA). The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.
Read the detailed description
This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with MTX in patients with active RA. The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.
- Conditions
- Rheumatoid Arthritis
- Being tested
- placebo, methotrexate, ocrelizumabu 50mg, ocrelizumabu 200mg, ocrelizumab 500mg
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Intravenous repeating dose
methotrexateDrug
Oral repeating dose
ocrelizumabu 50mgDrug
Intravenous repeating dose (50mg)
ocrelizumabu 200mgDrug
Intravenous repeating dose (200mg)
ocrelizumab 500mgDrug
Intravenous repeating dose (500mg)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: placebo; Drug: methotrexate |
| 2 | Experimental | Not described Receives: Drug: methotrexate; Drug: ocrelizumabu 50mg |
| 3 | Experimental | Not described Receives: Drug: methotrexate; Drug: ocrelizumabu 200mg |
| 4: | Experimental | Not described Receives: Drug: methotrexate; Drug: ocrelizumab 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with ACR20 response.
Measured: week 24
Secondary outcomes (7)
Percentage of patients with ACR20, 50, and 70 response, and the components of this outcome.
Measured: very 4 Weeks, from Week 4 to Week 24
EULAR response rate.
Measured: Every 4 Weeks, from Week 4 to Week 24
DAS 28, HAQ-DI score.
Measured: Every 4 Weeks, from Week 4 to Week 24
FACIT Fatigue Scale score
Measured: Weeks 4,12,and 24
Weeks 4,12,and 24
Measured: Length of study
Incidence of human anti-human(ocrelizumab) antibodies (HAHA)
Measured: Length of study
Pharmacokinetics and Pharmacodynamics of ocrelizumab.
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2010
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naritoshi Mochidome, Study chair, Chugai Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779220
- Sponsor's protocol ID
- JA21963
- Status last verified
- Mar 2015
- First submitted
- 23 Oct 2008
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Harigai M, Tanaka Y, Maisawa S; JA21963 Study Group. Safety and efficacy of various dosages of ocrelizumab in Japanese patients with rheumatoid arthritis with an inadequate response to methotrexate therapy: a placebo-controlled double-blind parallel-group study. J Rheumatol. 2012 Mar;39(3):486-95. doi: 10.3899/jrheum.110994. Epub 2012 Jan 15.
PubMed 22247354
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Study to Evaluate the Efficacy, Safety and PK/PD of Ocrelizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy
- ClinicalTrials.gov ID
- NCT00779220
- Acronym / sponsor ID
- JA21963
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 24 Oct 2008 (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 will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with methotrexate（MTX）in patients with active rheumatoid arthritis (RA). The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.
Detailed description
This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with MTX in patients with active RA. The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placebo, Drug: methotrexate |
| 2 | Experimental | Drug: methotrexate, Drug: ocrelizumabu 50mg |
| 3 | Experimental | Drug: methotrexate, Drug: ocrelizumabu 200mg |
| 4: | Experimental | Drug: methotrexate, Drug: ocrelizumab 500mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of RA for ≧6 months according to the revised 1987 ACR criteria for the classification of RA.
- Adult patients, ≧20 years of age.
- Receiving methotrexate at a dose of 6 to 8mg/week（oral）for ≧12 weeks, with a stable dose for the last 4 weeks before treatment.
- Positive serum RF.
Key exclusion criteria (4 listed)
- Rheumatic autoimmune disease other than RA, or Significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome).Patients with secondary Sjögren's syndrome or secondary limited cutaneous vasculitis with RA are eligible.
- Functional Class Ⅳ as defined by the ACR Classification of Functional Status in RA.
- History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome).
- Any surgical procedure (except for minor surgeries requiring local or no anaesthesia and without any complications or sequelae) within 12 weeks prior to or planned within 24 weeks after baseline.
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 |
|---|---|---|
| placeboIntravenous repeating dose | Drug | 1 |
| methotrexateOral repeating dose | Drug | 1, 2, 3, 4: |
| ocrelizumabu 50mgIntravenous repeating dose (50mg) | Drug | 2 |
| ocrelizumabu 200mgIntravenous repeating dose (200mg) | Drug | 3 |
| ocrelizumab 500mgIntravenous repeating dose (500mg) | Drug | 4: |
Primary outcome
Percentage of patients with ACR20 response.
Time frame: week 24
7 secondary outcomes
Percentage of patients with ACR20, 50, and 70 response, and the components of this outcome.
Time frame: very 4 Weeks, from Week 4 to Week 24
EULAR response rate.
Time frame: Every 4 Weeks, from Week 4 to Week 24
DAS 28, HAQ-DI score.
Time frame: Every 4 Weeks, from Week 4 to Week 24
FACIT Fatigue Scale score
Time frame: Weeks 4,12,and 24
Weeks 4,12,and 24
Time frame: Length of study
Incidence of human anti-human(ocrelizumab) antibodies (HAHA)
Time frame: Length of study
Pharmacokinetics and Pharmacodynamics of ocrelizumab.
Time frame: Length of study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Derived from this study: PubMed 22247354Harigai M, Tanaka Y, Maisawa S; JA21963 Study Group. Safety and efficacy of various dosages of ocrelizumab in Japanese patients with rheumatoid arthritis with an inadequate response to methotrexate therapy: a placebo-controlled double-blind parallel-group study. J Rheumatol. 2012 Mar;39(3):486-95. doi: 10.3899/jrheum.110994. Epub 2012 Jan 15.
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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.
Naritoshi Mochidome study chair
Chugai Pharmaceutical
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing methotrexate, ocrelizumabu 50mg and ocrelizumabu 200mg in people with Rheumatoid Arthritis, run by Chugai Pharmaceutical at 7 sites in Japan.
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 4 inclusion and 4 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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. 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 phase mean?
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. 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 patients with ACR20 response. (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00779220, which also lists 1 linked publication.
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 25 Mar 2015.