Rheumatoid ArthritisPhase 1NCT00965653
A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis
A Phase 1 study testing folic acid, methotrexate and tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 7 sites in 3 countries.
Trial summary
This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to 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?
- folic acid, methotrexate and tocilizumab [RoActemra/Actemra]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Aug 2009to Jul 2011
- 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
- adults 18 - 75 years of age
- active rheumatoid arthritis of >/= 6 months duration
- inadequate response to at least 12 weeks of methotrexate, the last 8 prior to baseline on stable dose
- swollen joint count (SJC)>/=4, tender joint count (TJC)>/=6 at screening and baseline
- DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline
- oral corticosteroids (</= 10mg/day prednisone or equivalent) and NSAIDS on stable dose </= 4 weeks prior to baseline
Who cannot join
- rheumatic autoimmune disease other than rheumatoid arthritis
- prior history or current inflammatory joint disease other than rheumatoid arthritis
- major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- functional class IV by ACR classification
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Canada3 sites
Study site
Kitchener, Ontario, N2M 5N6
Study site
St. John's, Newfoundland and Labrador, A1A 5E8
Study site
Trois-Rivières, Quebec, G8Z 1Y2
Spain3 sites
Study site
A Coruña, La Coruña, 15006
Study site
Santiago de Compostela, La Coruña, 15706
Study site
Seville, Sevilla, 41009
About this study
Official title: Open-label, Multicenter, Randomized, Parallel Study to Investigate pk, pd, Efficacy and Safety of Tocilizumab (TCZ, RO4877533) Following Subcutaneous Administration of TCZ 162 mg Weekly or Every Other Week in Combination With Methotrexate in Patients With Rheumatoid Arthritis
This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is < 50 individuals.
- Conditions
- Rheumatoid Arthritis
- Being tested
- folic acid, methotrexate, tocilizumab [RoActemra/Actemra]
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acidDrug
>/= 5 mg po weekly
methotrexateDrug
7.5 - 25 mg weekly (oral or parenteral)
tocilizumab [RoActemra/Actemra]Drug
162 mg sc weekly (QW)for 12 weeks
tocilizumab [RoActemra/Actemra]Drug
162 mg sc every other week (Q2W) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: folic acid; Drug: methotrexate; Drug: tocilizumab [RoActemra/Actemra] |
| 2 | Active comparator | Not described Receives: Drug: folic acid; Drug: methotrexate; Drug: tocilizumab [RoActemra/Actemra] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of TCZ after QW or Q2W sc administration
Measured: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up
Pharmacodynamic responses of CRP
Measured: sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment
Safety and tolerability, including injection site reaction
Measured: laboratory assessments every 2nd week on treatment and after 3 weeks follow-up, injection site evaluation after 1st, 2nd and last injection.
Secondary outcomes (2)
Efficacy according to ACR and DAS-EULAR parameters
Measured: assessments on day 1 of weeks 1, 4, 8 and 12
PD responses of IL-6, sIL-6R and anti TCZ antibody
Measured: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startAug 2009
- Study completionJul 2011
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 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
- NCT00965653
- Sponsor's protocol ID
- NP22623
- Other IDs
- 2009-011349-18, 2009
- Status last verified
- Nov 2016
- First submitted
- 18 Aug 2009
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Randomized, Parallel Study to Investigate pk, pd, Efficacy and Safety of Tocilizumab (TCZ, RO4877533) Following Subcutaneous Administration of TCZ 162 mg Weekly or Every Other Week in Combination With Methotrexate in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00965653
- Acronym / sponsor ID
- NP22623
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Study completion
- Jul 2011
- First posted
- 25 Aug 2009 (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 open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is < 50 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: folic acid, Drug: methotrexate, Drug: tocilizumab [RoActemra/Actemra] |
| 2 | Active comparator | Drug: folic acid, Drug: methotrexate, Drug: tocilizumab [RoActemra/Actemra] |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults 18 - 75 years of age
- active rheumatoid arthritis of >/= 6 months duration
- inadequate response to at least 12 weeks of methotrexate, the last 8 prior to baseline on stable dose
- swollen joint count (SJC)>/=4, tender joint count (TJC)>/=6 at screening and baseline
- DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline
Key exclusion criteria (4 listed)
- rheumatic autoimmune disease other than rheumatoid arthritis
- prior history or current inflammatory joint disease other than rheumatoid arthritis
- major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- functional class IV by ACR classification
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 |
|---|---|---|
| folic acid>/= 5 mg po weekly | Drug | 1, 2 |
| methotrexate7.5 - 25 mg weekly (oral or parenteral) | Drug | 1, 2 |
| tocilizumab [RoActemra/Actemra]162 mg sc weekly (QW)for 12 weeks | Drug | 1 |
| tocilizumab [RoActemra/Actemra]162 mg sc every other week (Q2W) for 12 weeks | Drug | 2 |
Primary outcome
Pharmacokinetics of TCZ after QW or Q2W sc administration
Time frame: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up
Pharmacodynamic responses of CRP
Time frame: sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment
Safety and tolerability, including injection site reaction
Time frame: laboratory assessments every 2nd week on treatment and after 3 weeks follow-up, injection site evaluation after 1st, 2nd and last injection.
2 secondary outcomes
Efficacy according to ACR and DAS-EULAR parameters
Time frame: assessments on day 1 of weeks 1, 4, 8 and 12
PD responses of IL-6, sIL-6R and anti TCZ antibody
Time frame: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up
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 Nov 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
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing folic acid, methotrexate and tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 7 sites in 3 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 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 2 Nov 2016. 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 Canada, Spain, 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?
Pharmacokinetics of TCZ after QW or Q2W sc administration (time frame: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up). The study lists 3 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 2 Nov 2016.