Trial Outcomes & Findings for A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417) (NCT NCT00741104)

Results Overview

Patients were asked as part of the Remicade questionnaire what dosing interval they were on.

Recruitment status

COMPLETED

Target enrollment

363 participants

Primary outcome timeframe

Measured from the Remicade Questionnaire at first (and only) study visit

Results posted on

2017-01-04

Participant Flow

Information about patients' doctor visits prior to this study were obtained from the Swedish Rheumatology Register and the South Swedish Arthritis Treatment Group.

RA patients in Sweden normally see their doctor every 6 months. Information obtained from these visits are entered into national registries. Data in this study were based on retrospective review of the two visits preceding the study visit and the visit when infliximab was prescribed for the 1st time, as well as the one and only study visit.

Participant milestones

Participant milestones
Measure	RA Patients Patients on maintenance therapy for rheumatoid arthritis (RA) with infliximab for \>= the past 12 months.
Overall Study STARTED	363
Overall Study COMPLETED	363
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RA Patients n=363 Participants Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for \>= the past 12 months.
Age, Continuous	61 years n=5 Participants
Gender Female	254 Participants n=5 Participants
Gender Male	109 Participants n=5 Participants
Region of Enrollment Sweden	363 participants n=5 Participants
Change in dosing interval since previous doctor visit Decreased dosing interval	19 participants n=5 Participants
Change in dosing interval since previous doctor visit No change	226 participants n=5 Participants
Change in dosing interval since previous doctor visit Increased dosing interval	19 participants n=5 Participants
Change in dosing interval since previous doctor visit Data unavailable	99 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured from the Remicade Questionnaire at first (and only) study visit

Patients were asked as part of the Remicade questionnaire what dosing interval they were on.

Outcome measures

Outcome measures
Measure	RA Patients n=363 Participants Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for \>= the past 12 months.
Dosing Interval Between the Infliximab Infusions < every 8 weeks	121 participants
Dosing Interval Between the Infliximab Infusions every 8 weeks	205 participants
Dosing Interval Between the Infliximab Infusions > every 8 weeks	37 participants

PRIMARY outcome

Timeframe: Measured from the Remicade Questionnaire at first (and only) study visit

Population: Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks.

Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.

Outcome measures

Outcome measures
Measure	RA Patients n=106 Participants Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for \>= the past 12 months.
Reason for Extending Dosing Interval decreased disease activity	24 participants
Reason for Extending Dosing Interval doctor's advice	31 participants
Reason for Extending Dosing Interval surgery/co-morbidity	28 participants
Reason for Extending Dosing Interval vacation/stay abroad	14 participants
Reason for Extending Dosing Interval pregnancy/trying to become pregnant	0 participants
Reason for Extending Dosing Interval other	9 participants

PRIMARY outcome

Timeframe: Measured from the Remicade Questionnaire at first (and only) study visit

Population: Among the 363 patients, 106 patients reported that they at SOME occasion during treatment with infliximab had had a longer dosing interval than every 8 weeks. Among the 106 patients who increased dosing interval, 79 noticed a difference. These 79 were analyzed for this measure.

Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked "did you notice any difference when your dosing interval was extended?" Those who noticed a difference were asked if their experience was positive or negative.

Outcome measures

Outcome measures
Measure	RA Patients n=79 Participants Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for \>= the past 12 months.
Patient Response to Increased Dosing Interval positive	4 participants
Patient Response to Increased Dosing Interval negative	75 participants

PRIMARY outcome

Timeframe: Measured from the Remicade Questionnaire at first (and only) study visit

Population: Out of the 363 subjects in the analysis, 361 subjects answered this question.

As part of the Remicade questionnaire, patients were asked "would you consider participating in a dose reduction study?"

Outcome measures

Outcome measures
Measure	RA Patients n=361 Participants Patients on maintenance therapy for Rheumatoid Arthritis (RA) with infliximab for \>= the past 12 months.
Number of Patients Agreeing to Participate in a Dose Reduction Study no	139 participants
Number of Patients Agreeing to Participate in a Dose Reduction Study yes	222 participants

SECONDARY outcome

Timeframe: Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.

This is not a prespecified key secondary outcome; therefore, results will not be disclosed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.

This is not a prespecified key secondary outcome; therefore, results will not be disclosed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.

This is not a prespecified key secondary outcome; therefore, results will not be disclosed

Outcome measures

Outcome data not reported

Adverse Events

RA Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck, Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI agrees not to publish/publicly present any interim results of the Study. PI further agrees to provide 45 days written notice to Sponsor prior to submission for publication/presentation to permit Sponsor to review drafts of any material before publication which report any results arising out of the Study. Sponsor shall have the right to review and comment.
Publication restrictions are in place

Restriction type: OTHER