Arthritis, PsoriaticNCT00725296

Investigation of 9 Consecutive Infusions of Remicade for Psoriatic Arthritis in Austria (Study P04264)

An observational study of Arthritis, Psoriatic, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time interval of Remicade (Infliximab) infusions in psoriatic arthritis (PsA). Read more about this study

Who is it for?: Any age
Conditions the study is for: Arthritis, Psoriatic
What is being tested?: Remicade (Infliximab)
Type of treatment: Injection or infusion
How many people: 178 participants
Where: No sites listed yet
Study dates: Dec 2004to Jul 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: Participants will receive Remicade induction therapy consisting of 3 infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of a maximum of 6 infusions given in doses and intervals due to the discretion of physicians.

Who may be able to join

Participants with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drugs.

Who cannot join

All according to contraindications in the label especially:
Participants with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
Participants with moderate or severe heart failure (NYHA class III/IV).
Participants with a history of hypersensitivity to infliximab or to other murine proteins, or to any of the excipients.

About this study

Official title: Remicade Therapy in Psoriatic Arthritis: 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 interval of Remicade (Infliximab) infusions in psoriatic arthritis (PsA).

Read the detailed description

This study population was chosen from a non-probability sample.

Conditions: Arthritis, Psoriatic
Being tested: Remicade (Infliximab)
Medical subject headings: Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remicade (Infliximab)Biological
Also called Remicade, SCH 215596
Induction infusions of Remicade will be administered at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians. A maximum of 6 maintenance infusions will be administered with the dosage and interval due to the discretion of the physicians.

Study groups in NCT00725296
Study group	Role	What they receive
Remicade (Infliximab)		Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs will receive induction infusions of Remicade at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians. A maximum of 6 maintenance infusions will be administered with the dosage and interval due to the discretion of the physicians. Whole observation period cannot exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in the Summary of Product Characteristics (SPC) is taken into consideration. Receives: Biological: Remicade (Infliximab)

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Time Interval Between Infusions During Maintenance Therapy
The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.
Measured: Up to 24 months
Median Time Interval Between Infusions During Maintenance Therapy
The median time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.
Measured: Up to 24 months
Average Dose During Induction Therapy and Subsequent Maintenance Therapy
The average dose per infusion measured in milligrams/killogram (mg/kg) in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).
Measured: Up to 24 Months
Median Dose During Induction Therapy and Subsequent Maintenance Therapy
The median dose per infusion measured in mg/kg in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).
Measured: Up to 24 Months
Average Overall Dose of All Infusions Per Participant
The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg.
Measured: Up to 24 Months
Median Dose of All Infusions Per Participant
The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.
Measured: Up to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2004Jul 2010

First posted30 Jul 2008 (estimated)
Study startDec 2004
Primary completionJul 2010
Study completionJul 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 Arthritis, PsoriaticStudies 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: 178 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00725296
Sponsor's protocol ID: P04264
Status last verified: Oct 2015
First submitted: 25 Jul 2008
Last updated: 5 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis

All Arthritis, Psoriatic trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Remicade Therapy in Psoriatic Arthritis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions
ClinicalTrials.gov ID: NCT00725296
Acronym / sponsor ID: P04264
Conditions: Arthritis, Psoriatic
Study type: Observational
Recruitment status: Completed
Enrolment: 178 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Centocor, Inc.
Study start: Dec 2004
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 30 Jul 2008 (estimated)
Results: Posted 29 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 interval of Remicade (Infliximab) infusions in psoriatic arthritis (PsA).

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 (Infliximab)	–	Biological: Remicade (Infliximab)Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs will receive induction infusions of Remicade at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians. A maximum of 6 maintenance infusions will be administered with the dosage and interval due to the discretion of the physicians. Whole observation period cannot exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in the 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: Participants will receive Remicade induction therapy consisting of 3 infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of a maximum of 6 infusions given in doses and intervals due to the discretion of physicians.

Key inclusion criteria (1 listed)

Participants with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drugs.

Key exclusion criteria (4 listed)

All according to contraindications in the label especially:

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
Remicade (Infliximab)Also: Remicade, SCH 215596Induction infusions of Remicade will be administered at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians. A maximum of 6 maintenance infusions will be administered with the dosage and interval due to the discretion of the physicians.	Biological	Remicade (Infliximab)

Primary outcome

Mean Time Interval Between Infusions During Maintenance Therapy
Time frame: Up to 24 months
The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.
Median Time Interval Between Infusions During Maintenance Therapy
Time frame: Up to 24 months
The median time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.
Average Dose During Induction Therapy and Subsequent Maintenance Therapy
Time frame: Up to 24 Months
The average dose per infusion measured in milligrams/killogram (mg/kg) in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).
Median Dose During Induction Therapy and Subsequent Maintenance Therapy
Time frame: Up to 24 Months
The median dose per infusion measured in mg/kg in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).
Average Overall Dose of All Infusions Per Participant
Time frame: Up to 24 Months
The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg.
Median Dose of All Infusions Per Participant
Time frame: Up to 24 Months
The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.

Results and safety

Results posted to the registry on 29 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infliximab	163	101

Primary outcome: Mean Time Interval Between Infusions During Maintenance Therapy

Time frame: Up to 24 months. Mean (Standard Deviation). Unit: days

Measure	Infliximab n = 83
Interval between infusion 3/4 (n= 83)	57.03 (7.83)
Interval between infusion 4/5 (n=83)	57.90 (7.97)
Interval between infusion 5/6 (n=79)	58.59 (12.28)
Interval between infusion 6/7 (n=77)	56.02 (10.59)
Interval between infusion 7/8 (n=73)	56.92 (10.76)
Interval between infusion 8/9 (n=70)	59.32 (18.39)

Population analysed: N= number of Infliximab-naive participants that received induction \& maintenance therapy. Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions).

Primary outcome: Median Time Interval Between Infusions During Maintenance Therapy

Time frame: Up to 24 months. Median (Full Range). Unit: days

Measure	Infliximab n = 83
Interval between infusion 3/4 (n= 83)	56 (36 to 84)
Interval between infusion 4/5 (n=83)	56 (41 to 84)
Interval between infusion 5/6 (n=79)	56 (30 to 114)
Interval between infusion 6/7 (n=77)	56 (33 to 115)
Interval between infusion 7/8 (n=73)	56 (35 to 119)
Interval between infusion 8/9 (n=70)	56 (35 to 159)

Primary outcome: Average Dose During Induction Therapy and Subsequent Maintenance Therapy

Time frame: Up to 24 Months. Mean (Standard Deviation). Unit: mg/kg

Measure	Infliximab n = 83
Infusion 1 (n=83)	3.92 (0.80)
Infusion 2 (n=83)	3.92 (0.81)
Infusion 3 (n=83)	3.98 (0.86)
Infusion 4 (n=83)	3.96 (0.87)
Infusion 5 (n=83)	3.94 (0.85)
Infusion 6 (n=79)	3.94 (0.85)
Infusion 7 (n=77)	3.97 (0.84)
Infusion 8 (n=73)	3.97 (0.87)

Primary outcome: Median Dose During Induction Therapy and Subsequent Maintenance Therapy

Time frame: Up to 24 Months. Median (Full Range). Unit: mg/kg

Measure	Infliximab n = 83
Infusion 1 (n=83)	3.75 (2.70 to 5.71)
Infusion 2 (n=83)	3.75 (2.70 to 5.71)
Infusion 3 (n=83)	3.75 (2.67 to 5.71)
Infusion 4 (n=83)	3.75 (2.67 to 5.71)
Infusion 5 (n=83)	3.75 (2.67 to 5.56)
Infusion 6 (n=79)	3.75 (2.67 to 5.56)
Infusion 7 (n=77)	3.75 (2.67 to 5.56)
Infusion 8 (n=73)	3.75 (2.63 to 5.63)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infliximab	6 of 163 (3.7%)	0 of 163 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arthritis, Psoriatic

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis

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, Psoriatic, 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 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 5 Nov 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 29 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 Infusions During Maintenance Therapy (time frame: Up to 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?

On the ClinicalTrials.gov record for NCT00725296.

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 5 Nov 2015.