Relapsing PolychondritisPhase 2NCT01104480
Tocilizumab for Relapsing Polychondritis
A Phase 2 study testing Tocilizumab in people with Relapsing Polychondritis, run by McMaster Children's Hospital at 1 site in Canada.
Trial summary
This is a study for one patient with severe relapsing polychondritis which has been unresponsive to other more conventional medications including prednisone, methotrexate, anakinra and TNF inhibitors. Tolerability, and efficacy of the drug, Tocilizumab will be monitored by clinical assessment and bloodwork. Read more about this study
- Who is it for?
- Ages 12 to 15 years, men only
- Conditions the study is for
- Relapsing Polychondritis
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to May 2012
- 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 12 to 15 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- A single patient with unremitting inflammatory relapsing polychondritis
Who cannot join
- As this is a study in a single patient, there are no exclusions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Tocilizumab in a Patient With Relapsing Polychondritis
This is a study for one patient with severe relapsing polychondritis which has been unresponsive to other more conventional medications including prednisone, methotrexate, anakinra and TNF inhibitors. Tolerability, and efficacy of the drug, Tocilizumab will be monitored by clinical assessment and bloodwork.
- Conditions
- Relapsing Polychondritis
- Being tested
- Tocilizumab
- Keywords
- Relapsing Polychondritis, Unremitting, Inflammation, IL6
- Medical subject headings
- Polychondritis, Relapsing, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called Actemra
Tocilizumab 8mg/kg every 2 weeks given by IV infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Tocilizumab
Inhibition of inflammatory markers Improvement in symptoms and signs
Measured: 2 years
Secondary outcomes (1)
Safety of Tocilizumab
Monitoring of serum lipids and liver function tests
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2010 (estimated)
- Study completionMay 2012 (estimated)
Why it stopped: Tocilizumab was licenced in Canada for children, so the study was not necessary
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing PolychondritisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Maggie Larche, McMaster Children's Hospital
- Investigators
- Maggie Larché, MD, PhD, Principal investigator, McMaster University and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104480
- Sponsor's protocol ID
- RP2010
- Status last verified
- May 2014
- First submitted
- 13 Apr 2010
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tocilizumab in a Patient With Relapsing Polychondritis
- ClinicalTrials.gov ID
- NCT01104480
- Acronym / sponsor ID
- RP2010
- Conditions
- Relapsing Polychondritis
- Keywords
- Relapsing Polychondritis, Unremitting, Inflammation, IL6
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Tocilizumab was licenced in Canada for children, so the study was not necessary
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2010 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 15 Apr 2010 (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 a study for one patient with severe relapsing polychondritis which has been unresponsive to other more conventional medications including prednisone, methotrexate, anakinra and TNF inhibitors. Tolerability, and efficacy of the drug, Tocilizumab will be monitored by clinical assessment and bloodwork.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 15 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- A single patient with unremitting inflammatory relapsing polychondritis
Key exclusion criteria (1 listed)
- As this is a study in a single patient, there are no exclusions
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 |
|---|---|---|
| TocilizumabAlso: ActemraTocilizumab 8mg/kg every 2 weeks given by IV infusion | Drug | – |
Primary outcome
Efficacy of Tocilizumab
Time frame: 2 years
Inhibition of inflammatory markers Improvement in symptoms and signs
1 secondary outcome
Safety of Tocilizumab
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
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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.
Maggie Larché, MD, PhD principal investigator
McMaster University and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocilizumab in people with Relapsing Polychondritis, run by McMaster Children's Hospital at 1 site in Canada.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 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 withdrawn before enrolling participants, so there are no results.
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?
Efficacy of Tocilizumab (time frame: 2 years). 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 13 May 2014.