A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250)

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 14-week non-interventional study will observe patients with rheumatoid arthritis (RA) who are being treated with infliximab for the first time, in order to learn about their disease characteristics. Patients in this study will be treated for RA with infliximab and in a usual manner as decided by their physician. Read more about this study

Who is it for?: Any age
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Infliximab
How many people: 728 participants
Where: No sites listed yet
Study dates: Dec 2005to Sep 2008
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 will be patients with rheumatoid arthritis in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European SPC of Remicade®). Subjects will be recruited from approximately 12 countries, including: Austria, Belgium, Denmark, France, Greece, the Netherlands, Norway, Poland, Portugal, Sweden, Switzerland and Turkey.

Who may be able to join

Subject has been diagnosed with RA
Physician has decided, with the subject's consent, to begin treatment with infliximab
Written informed consent form signed by both the subject and the physician.

Who cannot join

Subjects who have previously been exposed to infliximab

About this study

Official title: Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical Practice

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
Infliximab used in line with current clinical practice and local guidelines.

Study groups in NCT00705289
Study group	Role	What they receive
RA Subjects/ Infliximab 3 mg/kg		Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®). Receives: Biological: Infliximab

What is being measured

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

Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis.
Measured: At Baseline
Baseline Raw DAS28 by Time Since Diagnosis
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis.
Measured: At Baseline
Baseline Raw DAS28 by Gender
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis.
Measured: At Baseline
Baseline Raw DAS28 by Country of Residence
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis.
Measured: At Baseline
Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis.
Measured: At Baseline

Timeline

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

Dec 2005Sep 2008

First posted26 Jun 2008 (estimated)
Study startDec 2005
Primary completionSep 2008
Study completionSep 2008

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.
Publications (1)Papers the sponsor has linked to this study.
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: 728 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00705289
Sponsor's protocol ID: P04250
Acronym: REMARK
Status last verified: Jul 2015
First submitted: 23 Jun 2008
Last updated: 30 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Westhovens R, van Vollenhoven RF, Boumpas DT, Brzosko M, Svensson K, Bjorneboe O, Meeuwisse CM, Srinivasan S, Gaudin P, Smolen JS, Rahman MU, Nelissen RL, Vastesaeger N. The early clinical course of infliximab treatment in rheumatoid arthritis: results from the REMARK observational study. Clin Exp Rheumatol. 2014 May-Jun;32(3):315-23. Epub 2014 Feb 11.
PubMed 24529163

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 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical Practice
ClinicalTrials.gov ID: NCT00705289
Acronym / sponsor ID: REMARK / P04250
Conditions: Rheumatoid Arthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 728 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 26 Jun 2008 (estimated)
Results: Posted 10 Jun 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
RA Subjects/ Infliximab 3 mg/kg	–	Biological: InfliximabSubjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics [SPC] of Remicade®).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Subjects will be patients with rheumatoid arthritis in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European SPC of Remicade®). Subjects will be recruited from approximately 12 countries, including: Austria, Belgium, Denmark, France, Greece, the Netherlands, Norway, Poland, Portugal, Sweden, Switzerland and Turkey.

Key inclusion criteria (3 listed)

Subject has been diagnosed with RA
Physician has decided, with the subject's consent, to begin treatment with infliximab
Written informed consent form signed by both the subject and the physician.

Key exclusion criteria (1 listed)

Subjects who have previously been exposed to infliximab

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 used in line with current clinical practice and local guidelines.	Biological	RA Subjects/ Infliximab 3 mg/kg

Primary outcome

Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age
Time frame: At Baseline
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis.
Baseline Raw DAS28 by Time Since Diagnosis
Time frame: At Baseline
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis.
Baseline Raw DAS28 by Gender
Time frame: At Baseline
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis.
Baseline Raw DAS28 by Country of Residence
Time frame: At Baseline
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis.
Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
Time frame: At Baseline
Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis.

Results and safety

Results posted to the registry on 10 Jun 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RA Subjects/ Infliximab 3 mg/kg	728	597

Primary outcome: Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age

Time frame: At Baseline. Mean (Standard Deviation). Unit: Score on a scale

Measure	RA Subjects/ Infliximab 3 mg/kg n = 662
Value	5.2 (1.15)

RA Subjects/ Infliximab 3 mg/kg: Pearson Product Moment Correlation: 0.1402, p = 0.0003, Test for non-zero correlation

Population analysed: Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.

Primary outcome: Baseline Raw DAS28 by Time Since Diagnosis

Time frame: At Baseline. Mean (Standard Deviation). Unit: Score on a scale

Measure	RA Subjects/ Infliximab 3 mg/kg n = 662
Value	5.2 (1.15)

RA Subjects/ Infliximab 3 mg/kg: Pearson Product Moment Correlation: -0.01, p = 0.7991, Test for non-zero correlation

Primary outcome: Baseline Raw DAS28 by Gender

Time frame: At Baseline. Mean (Standard Deviation). Unit: Score on a scale

Measure	RA Subjects/ Infliximab 3 mg/kg n = 662	Male n = 140	Female n = 522
Value	5.2 (1.15)	5.23 (1.11)	5.19 (1.16)

Male vs Female: p = 0.7152, ANOVA

Primary outcome: Baseline Raw DAS28 by Country of Residence

Time frame: At Baseline. Mean (Standard Deviation). Unit: Score on a scale

Measure	Austria n = 55	Belgium n = 73	Denmark n = 24	France n = 104	Germany n = 67	Greece n = 78	Italy n = 32	Netherlands n = 17	Norway n = 41	Poland n = 51	Portugal n = 20	Sweden n = 100
Value	5.38 (0.90)	5.43 (1.22)	4.57 (1.16)	4.97 (1.12)	5.38 (1.23)	5.15 (1.14)	5.03 (1.05)	5.07 (1.23)	5.39 (1.13)	5.83 (0.87)	5.08 (1.48)	4.96 (1.09)

Austria vs Belgium vs Denmark vs France vs Germany vs Greece vs Italy vs Netherlands vs Norway vs Poland vs Portugal vs Sweden: p <0.0001, ANOVA

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infliximab 3 mg/kg	40 of 721 (5.5%)	0 of 721 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24529163Westhovens R, van Vollenhoven RF, Boumpas DT, Brzosko M, Svensson K, Bjorneboe O, Meeuwisse CM, Srinivasan S, Gaudin P, Smolen JS, Rahman MU, Nelissen RL, Vastesaeger N. The early clinical course of infliximab treatment in rheumatoid arthritis: results from the REMARK observational study. Clin Exp Rheumatol. 2014 May-Jun;32(3):315-23. Epub 2014 Feb 11.

Related trials for Rheumatoid Arthritis

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

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 3 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 30 Jul 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 10 Jun 2010). 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?

Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age (time frame: At Baseline). The study lists 5 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 NCT00705289, which also lists 1 linked publication.

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 Jul 2015.