Spondylitis, AnkylosingNCT00725543
Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)
An observational study of Spondylitis, Ankylosing, run by Merck Sharp & Dohme LLC.
Trial summary
This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time span of Remicade between infusions for ankylosing spondylitis (AS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spondylitis, Ankylosing
- What is being tested?
- Infliximab
- Type of treatment
- Injection or infusion
- How many people
- 358 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Jun 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with AS will receive Remicade induction therapy at specialized centers.
Who may be able to join
- Subjects with ankylosing spondylitis with severe axial symptoms and elevated serological markers of inflammatory activity.
Who cannot join
- Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
- Subjects with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV).
- Subjects with a history of hypersensitivity to Remicade or to other murine proteins, or to any of the excipients.
About this study
Official title: Remicade Therapy in Ankylosing Spondylitis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions
This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time span of Remicade between infusions for ankylosing spondylitis (AS).
Read the detailed description
This study population was chosen from a non-probability sample.
- Conditions
- Spondylitis, Ankylosing
- Being tested
- Infliximab
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabBiological
Also called Remicade, SCH 215596
Remicade induction therapy consists of 3 infusions given at weeks 0, 2, and 6 in specialized centers. Maintenance therapy will consist of a maximum of 6 infusions given in doses and intervals due to discretion of physicians.
| Study group | Role | What they receive |
|---|---|---|
| Remicade | Subjects with AS with severe axial symptoms and elevated serological markers of inflammatory activity will receive Remicade induction therapy consisting of 3 Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions given in doses and intervals due to discretion of physicians. Whole observation period cannot exceed 102 weeks per subject if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) is taken into consideration. Receives: Biological: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Measured: Maximum of 24 months
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Measured: Maximum of 24 months
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Measured: Maximum of 24 months.
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Measured: Maximum of 24 months.
Mean Remicade Dose Per Participant
Measured: Maximum of 24 months
Median Remicade Dose Per Participant
Measured: Maximum of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startJun 2004
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spondylitis, AnkylosingStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centocor, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725543
- Sponsor's protocol ID
- P04044
- Status last verified
- Sep 2015
- First submitted
- 25 Jul 2008
- Last updated
- 30 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remicade Therapy in Ankylosing Spondylitis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions
- ClinicalTrials.gov ID
- NCT00725543
- Acronym / sponsor ID
- P04044
- Conditions
- Spondylitis, Ankylosing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Centocor, Inc.
- Study start
- Jun 2004
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Posted 7 Jul 2011
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 prospective, open-label, 1-arm, multicenter observational study to determine the dose and time span of Remicade between infusions for ankylosing spondylitis (AS).
Detailed description
This study population was chosen from a non-probability sample.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remicade | – | Biological: InfliximabSubjects with AS with severe axial symptoms and elevated serological markers of inflammatory activity will receive Remicade induction therapy consisting of 3 Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions given in doses and intervals due to discretion of physicians. Whole observation period cannot exceed 102 weeks per subject if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) is taken into consideration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with AS will receive Remicade induction therapy at specialized centers.
Key inclusion criteria (1 listed)
- Subjects with ankylosing spondylitis with severe axial symptoms and elevated serological markers of inflammatory activity.
Key exclusion criteria (3 listed)
- Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
- Subjects with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV).
- Subjects with a history of hypersensitivity to Remicade or to other murine proteins, or to any of the excipients.
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 |
|---|---|---|
| InfliximabAlso: Remicade, SCH 215596Remicade induction therapy consists of 3 infusions given at weeks 0, 2, and 6 in specialized centers. Maintenance therapy will consist of a maximum of 6 infusions given in doses and intervals due to discretion of physicians. | Biological | Remicade |
Primary outcome
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Time frame: Maximum of 24 months
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Time frame: Maximum of 24 months
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Time frame: Maximum of 24 months.
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Time frame: Maximum of 24 months.
Mean Remicade Dose Per Participant
Time frame: Maximum of 24 months
Median Remicade Dose Per Participant
Time frame: Maximum of 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylitis, Ankylosing, run by Merck Sharp & Dohme LLC.
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 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 30 Sep 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy (time frame: Maximum of 24 months). The study lists 6 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 30 Sep 2015.