Arthritis, RheumatoidREMissionNCT00727298
Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840)
An observational study of Arthritis, Rheumatoid and Spondylitis, Ankylosing, run by Merck Sharp & Dohme LLC.
Trial summary
This study will be performed to evaluate and document the safety and efficacy of infliximab (Remicade®) in the treatment of chronic inflammatory diseases in big cohorts in the daily routine practice of rheumatologists, gastroenterologists, and dermatologists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic
- What is being tested?
- Infliximab
- How many people
- 4,485 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Aug 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants treated with infliximab by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.
Who may be able to join
- Participants treated with infliximab by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.
Who cannot join
- None
About this study
Official title: Post Marketing Surveillance Study of the Labeled Use of Remicade® (Infliximab) in Patients With Chronic Inflammatory Diseases
This study will be performed to evaluate and document the safety and efficacy of infliximab (Remicade®) in the treatment of chronic inflammatory diseases in big cohorts in the daily routine practice of rheumatologists, gastroenterologists, and dermatologists.
Read the detailed description
The study population was chosen from a non-probability sample.
The safety population consisted of all participants with at least one documented infusion of infliximab.
The evaluable population consisted of all participants that were >=18 years of age with a recorded indication for infliximab use, that had available baseline data, and with at least 3 infusions of infliximab within the first 16 weeks of the study. Baseline characteristics are provided for this population.
- Conditions
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Psoriasis, Crohn's Disease
- Being tested
- Infliximab
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Psoriasis, Crohn Disease
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
Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.
| Study group | Role | What they receive |
|---|---|---|
| Infliximab | Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease. Receives: Biological: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing at Least One Adverse Event
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event.
Measured: Baseline to Month 24
Secondary outcomes (2)
Clinicians' Impression of Disease Severity From Baseline to Week 102
Participant severity of disease was assessed at baseline, Week 6, Week 14, Week 22, Week 54, and Week 102 on the basis of the treating clinician's opinion of the participant being normal, not at all ill, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, or extreme severe illness. Each time point was compared to the previous visit.
Measured: Baseline, Week 6, Week 14, Week 22, Week 54, Week 102
Clinicians' Impression of Therapeutic Efficacy
Therapeutic efficacy was rated by the treating physician at each time point as moderate-to-clear improvement, no change, not assessable, mild-to-slight improvement, very good-to-full improvement, or worsened. Each time point was compared to the previous visit.
Measured: Week 6, Week 14, Week 22, Week 54, Week 102
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startFeb 2006
- Primary completionAug 2011
- Study completionAug 2011
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 Arthritis, RheumatoidStudies 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
- 4,485 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
- NCT00727298
- Sponsor's protocol ID
- P04840
- Acronym
- REMission
- Status last verified
- Nov 2015
- First submitted
- 30 Jul 2008
- Last updated
- 1 Dec 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 1 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study of the Labeled Use of Remicade® (Infliximab) in Patients With Chronic Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT00727298
- Acronym / sponsor ID
- REMission / P04840
- Conditions
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Psoriasis, Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,485 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Centocor, Inc.
- Study start
- Feb 2006
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Posted 12 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be performed to evaluate and document the safety and efficacy of infliximab (Remicade®) in the treatment of chronic inflammatory diseases in big cohorts in the daily routine practice of rheumatologists, gastroenterologists, and dermatologists.
Detailed description
The study population was chosen from a non-probability sample.
The safety population consisted of all participants with at least one documented infusion of infliximab.
The evaluable population consisted of all participants that were >=18 years of age with a recorded indication for infliximab use, that had available baseline data, and with at least 3 infusions of infliximab within the first 16 weeks of the study. Baseline characteristics are provided for this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infliximab | – | Biological: InfliximabInfliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants treated with infliximab by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.
Key inclusion criteria (1 listed)
- Participants treated with infliximab by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.
Key exclusion criteria (1 listed)
- None
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 215596Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease. | Biological | Infliximab |
Primary outcome
Number of Participants Experiencing at Least One Adverse Event
Time frame: Baseline to Month 24
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event.
2 secondary outcomes
Clinicians' Impression of Disease Severity From Baseline to Week 102
Time frame: Baseline, Week 6, Week 14, Week 22, Week 54, Week 102
Clinicians' Impression of Therapeutic Efficacy
Time frame: Week 6, Week 14, Week 22, Week 54, Week 102
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 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 Arthritis, Rheumatoid and 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 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: finished, as of the sponsor's last update on 1 Dec 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 12 Sep 2012). 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?
Number of Participants Experiencing at Least One Adverse Event (time frame: Baseline to Month 24). 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 1 Dec 2015.