Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)

An observational study of Rheumatoid Arthritis, 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 average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA) Read more about this study

Who is it for?: Any age
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Infliximab
Type of treatment: Injection or infusion
How many people: 516 participants
Where: No sites listed yet
Study dates: Mar 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: Patients with severe RA being treated at specialized centers.

Who may be able to join

Severe RA (indication according to Austrian labeling).

Who cannot join

According to Summary of Product Characteristics (SPC).

About this study

Official title: Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy

This is a prospective, open-label, 1-arm, multicenter observational study to determine the average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA)

Read the detailed description

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

Conditions: Rheumatoid Arthritis
Being tested: Infliximab
Medical subject headings: Arthritis, Rheumatoid

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 consisting of three 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.

Study groups in NCT00725621
Study group	Role	What they receive
Remicade		Patients with severe RA (indication according to Austrian labeling) will receive Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions. Remicade induction and maintenance therapy doses and intervals will be at the discretion of the physicians. 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
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Measured: Maximum of 16 weeks
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Measured: Maximum of 16 weeks
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Measured: Maximum of 102 weeks
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Measured: Maximum of 102 weeks
Mean Remicade Dose Per Participant
Measured: Maximum of 102 weeks
Median Remicade Dose Per Participant
Measured: Maximum of 102 weeks

Secondary outcomes (4)

Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy
Measured: 24 months maximum
Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Some participants had more than one previous treatment with a DMARD.
Measured: 24 months maximum
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)
Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS \& the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Measured: 24 months maximum
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS
Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS \& the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Measured: 24 months maximum

Timeline

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

Mar 2004Jul 2010

First posted30 Jul 2008 (estimated)
Study startMar 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 Rheumatoid ArthritisStudies 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: 516 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00725621
Sponsor's protocol ID: P03756
Status last verified: Sep 2015
First submitted: 25 Jul 2008
Last updated: 3 Sep 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

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy
ClinicalTrials.gov ID: NCT00725621
Acronym / sponsor ID: P03756
Conditions: Rheumatoid Arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 516 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Centocor, Inc.
Study start: Mar 2004
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 30 Jul 2008 (estimated)
Results: Posted 4 Aug 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 average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA)

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: InfliximabPatients with severe RA (indication according to Austrian labeling) will receive Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions. Remicade induction and maintenance therapy doses and intervals will be at the discretion of the physicians.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with severe RA being treated at specialized centers.

Key inclusion criteria (1 listed)

Severe RA (indication according to Austrian labeling).

Key exclusion criteria (1 listed)

According to Summary of Product Characteristics (SPC).

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 consisting of three 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.	Biological	Remicade

Primary outcome

Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Time frame: Maximum of 16 weeks
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Time frame: Maximum of 16 weeks
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Time frame: Maximum of 102 weeks
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Time frame: Maximum of 102 weeks
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Mean Remicade Dose Per Participant
Time frame: Maximum of 102 weeks
Median Remicade Dose Per Participant
Time frame: Maximum of 102 weeks

4 secondary outcomes

Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy
Time frame: 24 months maximum
Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Time frame: 24 months maximum
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)
Time frame: 24 months maximum
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS
Time frame: 24 months maximum

Results and safety

Results posted to the registry on 4 Aug 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
Remicade (Specialized Hospitals & Extramural Infusion Centers)	516	245

Primary outcome: Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy

Time frame: Maximum of 16 weeks. Mean (Standard Deviation). Unit: Days

Measure	Remicade (Specialized Hospitals & Extramural Infusion Centers) n = 193	Remicade (Specialized Hospitals Only) n = 120	Remicade (Extramural Infusion Centers Only) n = 73
Infusion 3/4 (n=193, n=120, n=73)	56.48 (10.94)	56.32 (7.76)	56.75 (14.82)
Infusion 4/5 (n=193, n=120, n=73)	57.55 (10.81)	56.83 (10.66)	58.73 (11.03)
Infusion 5/6 (n=178, n=110, n=68)	56.80 (10.85)	56.60 (13.07)	57.13 (5.75)
Infusion 6/7 (n=163, n=99, n=64)	56.07 (8.57)	55.41 (8.56)	57.09 (8.56)
Infusion 7/8 (n=153, n=91, n=62)	57.33 (10.97)	56.43 (12.11)	58.65 (8.97)
Infusion 8/9 (n=143, n=83, n=60)	57.04 (11.07)	56.60 (12.49)	57.65 (8.80)

Population analysed: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.

Primary outcome: Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy

Time frame: Maximum of 16 weeks. Median (Full Range). Unit: Days

Measure	Remicade (Specialized Hospitals & Extramural Infusion Centers) n = 193	Remicade (Specialized Hospitals Only) n = 120	Remicade (Extramural Infusion Centers Only) n = 73
Infusion 3/4 (n=193, n=120, n=73)	57.00 (25.00 to 135.00)	57.00 (29.00 to 85.00)	57.00 (25.00 to 135.00)
Infusion 4/5 (n=193, n=120, n=73)	57.00 (41.00 to 120.00)	57.00 (41.00 to 116.00)	57.00 (43.00 to 120.00)
Infusion 5/6 (n=178, n=110, n=68)	57.00 (30.00 to 140.00)	57.00 (30.00 to 140.00)	57.00 (42.00 to 71.00)
Infusion 6/7 (n=163, n=99, n-64)	57.00 (30.00 to 106.00)	57.00 (41.00 to 92.00)	57.00 (30.00 to 106.00)
Infusion 7/8 (n=153, n=91, n=62)	57.00 (13.00 to 112.00)	57.00 (13.00 to 97.00)	57.00 (44.00 to 112.00)
Infusion 8/9 (n=143, n=83, n=60)	57.00 (24.00 to 113.00)	57.00 (24.00 to 113.00)	57.00 (43.00 to 111.00)

Population analysed: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.

Primary outcome: Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy

Time frame: Maximum of 102 weeks. Mean (Standard Deviation). Unit: milligrams/kilograms (mg/kg)

Measure	Remicade (Specialized Hospitals & Extramural Infusion Centers) n = 193	Remicade (Specialized Hospitals Only) n = 120	Remicade (Extramural Infusion Centers Only) n = 73
Infusion 1 (n=193, n=120, n=73)	3.42 (0.59)	3.50 (0.59)	3.30 (0.56)
Infusion 2 (n=192, n=119, n=73)	3.43 (0.59)	3.51 (0.59)	3.31 (0.56)
Infusion 3 (n=193, n=120, n=73)	3.46 (0.62)	3.56 (0.65)	3.30 (0.54)
Infusion 4 (n=193, n=120, n=73)	3.50 (0.62)	3.59 (0.63)	3.36 (0.57)
Infusion 5 (n=193, n=120, n=73)	3.53 (0.67)	3.62 (0.71)	3.36 (0.58)
Infusion 6 (n=178, n=110, n=68)	3.56 (0.70)	3.70 (0.75)	3.34 (0.54)
Infusion 7 (n=163, n=99, n=64)	3.63 (0.74)	3.78 (0.82)	3.39 (0.53)
Infusion 8 (n=153, n=91, n=62)	3.60 (0.72)	3.75 (0.79)	3.37 (0.53)

Population analysed: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.

Primary outcome: Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy

Time frame: Maximum of 102 weeks. Median (Full Range). Unit: mg/kg

Measure	Remicade (Specialized Hospitals & Extramural Infusion Centers) n = 193	Remicade (Specialized Hospitals Only) n = 120	Remicade (Extramural Infusion Centers Only) n = 73
Infusion 1 (n=193, n=120, n=73)	3.33 (2.25 to 6.15)	3.38 (2.45 to 5.97)	3.23 (2.25 to 6.15)
Infusion 2 (n=192, n=119, n=73)	3.33 (2.25 to 6.15)	3.39 (2.56 to 5.97)	3.23 (2.25 to 6.15)
Infusion 3 (n=193, n=120, n=73)	3.33 (2.22 to 5.97)	3.40 (2.22 to 5.88)	3.23 (2.41 to 5.97)
Infusion 4 (n=193, n=120, n=73)	3.41 (2.44 to 5.80)	3.49 (2.50 to 5.80)	3.33 (2.44 to 5.80)
Infusion 5 (n=193, n=120, n=73)	3.39 (2.08 to 5.71)	3.53 (2.08 to 5.48)	3.33 (2.35 to 5.71)
Infusion 6 (n=178, n=110, n=68)	3.41 (2.13 to 5.71)	3.61 (2.13 to 5.48)	3.33 (2.35 to 5.71)
Infusion 7 (n=163, n=99, n=64)	3.53 (2.13 to 5.71)	3.70 (2.13 to 5.66)	3.33 (2.56 to 5.71)
Infusion 8 (n=153, n=91, n=62)	3.53 (2.13 to 5.71)	3.70 (2.13 to 5.56)	3.33 (2.50 to 5.71)

Population analysed: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Remicade (Specialized Hospitals & Extramural Infusion Centers)	21 of 516 (4.1%)	0 of 516 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 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 Rheumatoid Arthritis, 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 3 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 4 Aug 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 16 weeks). 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 NCT00725621.

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 3 Sep 2015.