PolymyositisPhase 2/3NCT01165008
Anakinra in Myositis
A Phase 2/3 study testing Anakinra in people with Polymyositis and Dermatomyositis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients with treatment-resistant inflammatory myopathies. Patients and methods: Fifteen patients with refractory polymyositis (PM), dermatomyositis (DM), or inclusion body myositis (IBM) were treated with 100 mg anakinra subcutaneously… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Polymyositis, Dermatomyositis, Inclusion Body Myositis
- What is being tested?
- Anakinra
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Sep 2003to Sep 2008
- Phase
- Phase 2/3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 80 years with diagnosis of PM, DM or IBM based Peter and Bohan's and Grigg's criteria. All patients had to be capable of giving informed consent. Other inclusion criteria were muscle strength and/or function reduced at least 20 % below predicted values as measured by functional index (FI) [45-47] and failure to respond to treatment with high-dose glucocorticoids (0.75 mg/kg/day for at least one month) in combination with azathioprine and/or methotrexate for at least two months.
- -
Who cannot join
- serious infections such as hepatitis, pneumonia, pyelonephritis in the previous 3 months; history of opportunistic infections such as tuberculosis, drug resistant atypical mycobacterium, active pneumocystis carinii, active cytomegalovirus infection; documented HIV infection; alcoholism, alcoholic liver disease or other chronic liver disease; chest x-ray suggestive of active tuberculosis; and pregnant, nursing mothers or patients with planned pregnancy within one and a half years of enrolment.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anakinra in Patients With Refractory Idiopathic Inflammatory Myopathies
To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients with treatment-resistant inflammatory myopathies.
Patients and methods: Fifteen patients with refractory polymyositis (PM), dermatomyositis (DM), or inclusion body myositis (IBM) were treated with 100 mg anakinra subcutaneously per day during 12 months. Outcome measures included myositis disease activity score with improvement defined according to The International Myositis Assessment and Clinical Studies Group (IMACS) and for muscle performance the functional index of myositis (FI). In addition repeat muscle biopsies were performed
- Conditions
- Polymyositis, Dermatomyositis, Inclusion Body Myositis
- Being tested
- Anakinra
- Medical subject headings
- Polymyositis, Dermatomyositis, Myositis, Inclusion Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startSep 2003
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolymyositisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165008
- Sponsor's protocol ID
- KS 01
- Other IDs
- 03-144
- Status last verified
- Feb 2005
- First submitted
- 16 Jul 2010
- Last updated
- 19 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anakinra in Patients With Refractory Idiopathic Inflammatory Myopathies
- ClinicalTrials.gov ID
- NCT01165008
- Acronym / sponsor ID
- KS 01
- Conditions
- Polymyositis, Dermatomyositis, Inclusion Body Myositis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- Sep 2008 (actual)
- First posted
- 19 Jul 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.
To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients with treatment-resistant inflammatory myopathies.
Patients and methods: Fifteen patients with refractory polymyositis (PM), dermatomyositis (DM), or inclusion body myositis (IBM) were treated with 100 mg anakinra subcutaneously per day during 12 months. Outcome measures included myositis disease activity score with improvement defined according to The International Myositis Assessment and Clinical Studies Group (IMACS) and for muscle performance the functional index of myositis (FI). In addition repeat muscle biopsies were performed
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged 18 to 80 years with diagnosis of PM, DM or IBM based Peter and Bohan's and Grigg's criteria. All patients had to be capable of giving informed consent. Other inclusion criteria were muscle strength and/or function reduced at least 20 % below predicted values as measured by functional index (FI) [45-47] and failure to respond to treatment with high-dose glucocorticoids (0.75 mg/kg/day for at least one month) in combination with azathioprine and/or methotrexate for at least two months.
- -
Key exclusion criteria (2 listed)
- serious infections such as hepatitis, pneumonia, pyelonephritis in the previous 3 months; history of opportunistic infections such as tuberculosis, drug resistant atypical mycobacterium, active pneumocystis carinii, active cytomegalovirus infection; documented HIV infection; alcoholism, alcoholic liver disease or other chronic liver disease; chest x-ray suggestive of active tuberculosis; and pregnant, nursing mothers or patients with planned pregnancy within one and a half years of enrolment.
- -
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 |
|---|---|---|
| Anakinra | Drug | – |
Primary outcome
Not reported in the source record.
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 19 Jul 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anakinra in people with Polymyositis and Dermatomyositis, run by Karolinska Institutet at 1 site in Sweden.
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 2 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 19 Jul 2010. 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 Sweden. 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 combined 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.
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.
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 19 Jul 2010.