Rheumatoid ArthritisPhase 3NCT00144521
Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)
A Phase 3 study testing MRA(Tocilizumab) and MTX in people with Rheumatoid Arthritis, run by Chugai Pharmaceutical.
Trial summary
The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- MRA(Tocilizumab) and MTX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Apr 2006
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of RA based on the 1987 classification criteria of the American College of Rheumatology (ACR)
- Disease duration of 6 months or more
- Treated with 8 mg/week of MTX for at least 8 weeks immediately preceding enrollment, and continued on this treatment up to initiation of the study drug
- Active disease at enrollment (less than 2 weeks before initiating treatment with a study drug), Which is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 1.0 mg/dL
Who cannot join
- Assessed as having Class IV Steinbrocker functional activity in the 4 weeks preceding treatment with the study drug
- Treated with infliximab, etanercept or leflunomide in the 12 weeks preceding treatment with the study drug
- Received any of the following therapies in the 2 weeks preceding initiation of treatment with the study drug.
- Administration of any DMARD or immunosuppressant other than MTX
- Administration of corticosteroids exceeding 10 mg/day as prednisolone
- Dose escalation or initiation of corticosteroids
Show all 9Show fewer
- Received any of the following therapies in the 4 weeks preceding treatment with the study drug
- Plasma exchange therapy
- Surgical treatment (operation, etc.)
About this study
Official title: A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.
- Conditions
- Rheumatoid Arthritis
- Being tested
- MRA(Tocilizumab), MRA placebo, MTX, MTX 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.
MRA(Tocilizumab)Drug
8mg/kg/4week(i.v.)for 24 weeks
MRA placeboDrug
0mg/kg/4week(i.v.) for 24 weeks
MTXDrug
8mg/week(p.o.) for 24 weeks
MTX placeboDrug
0mg/week(p.o.) for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MRA(Tocilizumab); Drug: MTX placebo |
| 2 | Active comparator | Not described Receives: Drug: MRA placebo; Drug: MTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of ACR 20% improvement
Measured: week 24
Secondary outcomes (3)
Frequency and severity of adverse events and adverse drug reactions
Measured: throughout study
Time course of DAS28
Measured: throughout study
time course of the frequency of ACR 20%, 50% and 70%
Measured: throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionAug 2004
- Study completionApr 2006
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Takahiro Kakehi, Study director, Chugai Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144521
- Sponsor's protocol ID
- MRA213JP
- Status last verified
- Jan 2009
- First submitted
- 2 Sep 2005
- Last updated
- 2 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
- ClinicalTrials.gov ID
- NCT00144521
- Acronym / sponsor ID
- MRA213JP
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Aug 2004 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 5 Sep 2005 (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.
The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MRA(Tocilizumab), Drug: MTX placebo |
| 2 | Active comparator | Drug: MRA placebo, Drug: MTX |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of RA based on the 1987 classification criteria of the American College of Rheumatology (ACR)
- Disease duration of 6 months or more
- Treated with 8 mg/week of MTX for at least 8 weeks immediately preceding enrollment, and continued on this treatment up to initiation of the study drug
- Active disease at enrollment (less than 2 weeks before initiating treatment with a study drug), Which is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 1.0 mg/dL
Key exclusion criteria (9 listed)
- Assessed as having Class IV Steinbrocker functional activity in the 4 weeks preceding treatment with the study drug
- Treated with infliximab, etanercept or leflunomide in the 12 weeks preceding treatment with the study drug
- Received any of the following therapies in the 2 weeks preceding initiation of treatment with the study drug.
- Received any of the following therapies in the 4 weeks preceding treatment with the study drug
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 |
|---|---|---|
| MRA(Tocilizumab)8mg/kg/4week(i.v.)for 24 weeks | Drug | 1 |
| MRA placebo0mg/kg/4week(i.v.) for 24 weeks | Drug | 2 |
| MTX8mg/week(p.o.) for 24 weeks | Drug | 2 |
| MTX placebo0mg/week(p.o.) for 24 weeks | Drug | 1 |
Primary outcome
Frequency of ACR 20% improvement
Time frame: week 24
3 secondary outcomes
Frequency and severity of adverse events and adverse drug reactions
Time frame: throughout study
Time course of DAS28
Time frame: throughout study
time course of the frequency of ACR 20%, 50% and 70%
Time frame: throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2009.
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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.
Takahiro Kakehi study director
Chugai Pharmaceutical
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MRA(Tocilizumab) and MTX in people with Rheumatoid Arthritis, run by Chugai Pharmaceutical.
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 9 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: finished, as of the sponsor's last update on 2 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of ACR 20% improvement (time frame: week 24). 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 2 Feb 2009.