Rheumatoid ArthritisPhase 1NCT00365001
A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.
A Phase 1 study testing tocilizumab [RoActemra/Actemra], Methotrexate and Simvastatin in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 11 sites in 2 countries.
Trial summary
This 2 arm study will investigate the pharmacokinetics of simvastatin and methotrexate in combination with tocilizumab to assess any potential drug interactions. Patients will be randomized to receive either tocilizumab (10mg/kg iv infusion on day 8) + methotrexate (10-25mg po /week) or tocilizumab + methotrexate +… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- tocilizumab [RoActemra/Actemra], Methotrexate and Simvastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Start not givento Apr 2008
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 18-75 years of age;
- rheumatoid arthritis for >=6 months;
- methotrexate for >=12 weeks prior to day 1 (stable at 10-25mg/week for 8 weeks).
Who cannot join
- history of, or current inflammatory joint disease or rheumatic autoimmune disease other than RA;
- concurrent treatment with any DMARD other than methotrexate;
- prior treatment with tocilizumab.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Study site
Anniston, Alabama, 36207
Study site
Austin, Texas, 78704
Study site
Duncansville, Pennsylvania, 16635
Study site
Jacksonville, Florida, 32216
Study site
Little Rock, Arkansas, 72202
Study site
Oklahoma City, Oklahoma, 73103
Study site
Omaha, Nebraska, 68154
Study site
Palm Harbor, Florida, 34684
Study site
Royal Oak, Michigan, 48073
Study site
Scottsdale, Arizona, 85251
About this study
Official title: A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.
This 2 arm study will investigate the pharmacokinetics of simvastatin and methotrexate in combination with tocilizumab to assess any potential drug interactions. Patients will be randomized to receive either tocilizumab (10mg/kg iv infusion on day 8) + methotrexate (10-25mg po /week) or tocilizumab + methotrexate + simvastatin (40mg po on days 1, 15 and 43). Blood samples will be taken for analysis at intervals up to day 44. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
- Conditions
- Rheumatoid Arthritis
- Being tested
- tocilizumab [RoActemra/Actemra], Methotrexate, Simvastatin
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tocilizumab [RoActemra/Actemra]Drug
10mg/kg iv on day 8
MethotrexateDrug
10-25mg po/week
SimvastatinDrug
40mg po on days 1, 15 and 43
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: tocilizumab [RoActemra/Actemra]; Drug: Methotrexate; Drug: Simvastatin |
| 2 | Active comparator | Not described Receives: Drug: tocilizumab [RoActemra/Actemra]; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.
Measured: Days 1, 15 and 43
Secondary outcomes (3)
Pharmacokinetic parameters for tocilizumab.
Measured: Days 11, 22, 29 and 36.
CRP, IL-6, sIL-6R changes
Measured: Throughout study
AEs, laboratory parameters.
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 posted16 Aug 2006 (estimated)
- Study completionApr 2008
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365001
- Sponsor's protocol ID
- WP18663
- Status last verified
- Jun 2010
- First submitted
- 15 Aug 2006
- Last updated
- 11 Jun 2010
- Results posted
- No
Publications
Schmitt C, Kuhn B, Zhang X, Kivitz A, Grange S. Tocilizumab has no clinically relevant effects on methotrexate pharmacokinetics in patients with rheumatoid arthritis. Int J Clin Pharmacol Ther. 2012 Mar;50(3):218-23. doi: 10.5414/cp201613.
PubMed 22373834
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT00365001
- Acronym / sponsor ID
- WP18663
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study completion
- Apr 2008 (actual)
- First posted
- 16 Aug 2006 (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 2 arm study will investigate the pharmacokinetics of simvastatin and methotrexate in combination with tocilizumab to assess any potential drug interactions. Patients will be randomized to receive either tocilizumab (10mg/kg iv infusion on day 8) + methotrexate (10-25mg po /week) or tocilizumab + methotrexate + simvastatin (40mg po on days 1, 15 and 43). Blood samples will be taken for analysis at intervals up to day 44. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tocilizumab [RoActemra/Actemra], Drug: Methotrexate, Drug: Simvastatin |
| 2 | Active comparator | Drug: tocilizumab [RoActemra/Actemra], Drug: Methotrexate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients, 18-75 years of age;
- rheumatoid arthritis for >=6 months;
- methotrexate for >=12 weeks prior to day 1 (stable at 10-25mg/week for 8 weeks).
Key exclusion criteria (3 listed)
- history of, or current inflammatory joint disease or rheumatic autoimmune disease other than RA;
- concurrent treatment with any DMARD other than methotrexate;
- prior treatment with tocilizumab.
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 |
|---|---|---|
| tocilizumab [RoActemra/Actemra]10mg/kg iv on day 8 | Drug | 1, 2 |
| Methotrexate10-25mg po/week | Drug | 1, 2 |
| Simvastatin40mg po on days 1, 15 and 43 | Drug | 1 |
Primary outcome
Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.
Time frame: Days 1, 15 and 43
3 secondary outcomes
Pharmacokinetic parameters for tocilizumab.
Time frame: Days 11, 22, 29 and 36.
CRP, IL-6, sIL-6R changes
Time frame: Throughout study
AEs, laboratory parameters.
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 11 Jun 2010.
- Derived from this study: PubMed 22373834Schmitt C, Kuhn B, Zhang X, Kivitz A, Grange S. Tocilizumab has no clinically relevant effects on methotrexate pharmacokinetics in patients with rheumatoid arthritis. Int J Clin Pharmacol Ther. 2012 Mar;50(3):218-23. doi: 10.5414/cp201613.
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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
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tocilizumab [RoActemra/Actemra], Methotrexate and Simvastatin in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 11 sites in 2 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 3 inclusion and 3 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 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, New Zealand. 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. 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 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.
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?
Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite. (time frame: Days 1, 15 and 43). 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 NCT00365001, 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 11 Jun 2010.