Rheumatoid ArthritisPhase 2NCT00144651
Study of MRA in Patients With Rheumatoid Arthritis (RA)
A Phase 2 study testing MRA(Tocilizumab) in people with Rheumatoid Arthritis, run by Chugai Pharmaceutical.
Trial summary
This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP. 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?
- MRA(Tocilizumab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Jun 2009
- 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
- Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety.
- Patients confirmed to have shown the safety in the preceding study.
Who cannot join
- Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug
- Patients who received any of the following treatments between the start of preceding study and the registration of this study.
- Plasma exchange therapy
- Surgical treatment (e.g., operation)
About this study
Official title: An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JP
This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.
- Conditions
- Rheumatoid Arthritis
- Being tested
- MRA(Tocilizumab)
- 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/4 weeks for 1 year
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MRA(Tocilizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR 20% responder rate compared to the pre-treatment in the preceding study
Measured: throughout study
Frequency and severity of adverse events and adverse drug reactions
Measured: week0,week4,week8,week12,and LOBS
Secondary outcomes (4)
Time course of DAS28,compared to the pre-treatment in the preceding study
Measured: week 0,week 4,week 8,week 12, LOBS
Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study
Measured: week 0,week 4,week 8,week 12, LOBS
ACR N AUC compared to the pre-treatment in the preceding study
Measured: week 0,week 4,week 8,week 12, LOBS
Time course of the ACR core set variables compared to the pre-treatment in the preceding study
Measured: week 0,week 4,week 8,week 12, LOBS
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 startAug 2001
- Primary completionJun 2009
- Study completionJun 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takahiro Kakehi, Study director, Chugai Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144651
- Sponsor's protocol ID
- MRA010JP
- Status last verified
- Aug 2013
- First submitted
- 2 Sep 2005
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JP
- ClinicalTrials.gov ID
- NCT00144651
- Acronym / sponsor ID
- MRA010JP
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (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.
This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MRA(Tocilizumab) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety.
- Patients confirmed to have shown the safety in the preceding study.
Key exclusion criteria (4 listed)
- Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug
- Patients who received any of the following treatments between the start of preceding study and the registration of this study.
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/4 weeks for 1 year | Drug | 1 |
Primary outcome
ACR 20% responder rate compared to the pre-treatment in the preceding study
Time frame: throughout study
Frequency and severity of adverse events and adverse drug reactions
Time frame: week0,week4,week8,week12,and LOBS
4 secondary outcomes
Time course of DAS28,compared to the pre-treatment in the preceding study
Time frame: week 0,week 4,week 8,week 12, LOBS
Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study
Time frame: week 0,week 4,week 8,week 12, LOBS
ACR N AUC compared to the pre-treatment in the preceding study
Time frame: week 0,week 4,week 8,week 12, LOBS
Time course of the ACR core set variables compared to the pre-treatment in the preceding study
Time frame: week 0,week 4,week 8,week 12, LOBS
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 9 Aug 2013.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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 2 study testing MRA(Tocilizumab) 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 2 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: finished, as of the sponsor's last update on 9 Aug 2013. 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 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 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?
ACR 20% responder rate compared to the pre-treatment in the preceding study (time frame: throughout study). 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 9 Aug 2013.