Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Collaborator:
Centocor, Inc.
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00725621
First received: July 25, 2008
Last updated: July 8, 2011
Last verified: July 2011
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Results First Received: July 8, 2011
| Study Type: | Observational |
|---|---|
| Study Design: | Observational Model: Cohort; Time Perspective: Prospective |
| Condition: |
Rheumatoid Arthritis |
| Intervention: |
Biological: Infliximab |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration. |
Participant Flow: Overall Study
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | |
|---|---|
| STARTED | 516 [1] |
| COMPLETED | 245 [2] |
| NOT COMPLETED | 271 |
| Adverse Event | 25 |
| Lack of Efficacy | 46 |
| Withdrawal by Subject | 57 |
| Physician Decision | 19 |
| Lost to Follow-up | 52 |
| Non-compliance | 8 |
| Continued treatment by other physician | 6 |
| Switched to other study | 1 |
| Switched to other drug | 1 |
| Prepared for elective surgery | 1 |
| Reason not specified | 55 |
| [1] | Started was defined as the number of participants who received at least one infusion of Remicade. |
|---|---|
| [2] | Completed was defined as the number of participants who received 9 consecutive Remicade infusions. |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration. |
Baseline Measures
| Remicade (Specialized Hospitals & Extramural Infusion Centers) | |
|---|---|
|
Number of Participants
[units: participants] |
516 |
|
Age
[units: years] Mean ± Standard Deviation |
55.43 ± 13.52 |
|
Gender
[units: participants] |
|
| Female | 398 |
| Male | 118 |
Outcome Measures
| 1. Primary: | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy [ Time Frame: Maximum of 16 weeks ] |
| 2. Primary: | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy [ Time Frame: Maximum of 16 weeks ] |
| 3. Primary: | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy [ Time Frame: Maximum of 102 weeks ] |
| 4. Primary: | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy [ Time Frame: Maximum of 102 weeks ] |
| 5. Primary: | Mean Remicade Dose Per Participant [ Time Frame: Maximum of 102 weeks ] |
| 6. Primary: | Median Remicade Dose Per Participant [ Time Frame: Maximum of 102 weeks ] |
| 7. Secondary: | Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy [ Time Frame: 24 months maximum ] |
| 8. Secondary: | Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) [ Time Frame: 24 months maximum ] |
| 9. Secondary: | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) [ Time Frame: 24 months maximum ] |
| 10. Secondary: | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS [ Time Frame: 24 months maximum ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |
Results Point of Contact:
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00725621 History of Changes |
| Other Study ID Numbers: | P03756 |
| Study First Received: | July 25, 2008 |
| Results First Received: | July 8, 2011 |
| Last Updated: | July 8, 2011 |
| Health Authority: | Austria: Not Required |