Spondylitis, Ankylosing
Conditions
Brief summary
This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time span of Remicade between infusions for ankylosing spondylitis (AS).
Detailed description
This study population was chosen from a non-probability sample.
Interventions
BIOLOGICALInfliximab
Remicade induction therapy consists of 3 infusions given at weeks 0, 2, and 6 in specialized centers. Maintenance therapy will consist of a maximum of 6 infusions given in doses and intervals due to discretion of physicians.
Sponsors
Centocor, Inc.
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects with ankylosing spondylitis with severe axial symptoms and elevated serological markers of inflammatory activity.
Exclusion criteria
* Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections. * Subjects with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV). * Subjects with a history of hypersensitivity to Remicade or to other murine proteins, or to any of the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Maximum of 24 months |
| Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Maximum of 24 months |
| Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Maximum of 24 months. |
| Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Maximum of 24 months. |
| Mean Remicade Dose Per Participant | Maximum of 24 months |
| Median Remicade Dose Per Participant | Maximum of 24 months |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Remicade Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 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. | 358 |
| Total | 358 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 10 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Non-compliance | 2 |
| Overall Study | Other | 119 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Remicade |
|---|---|
| Age, Continuous | 42.08 years STANDARD_DEVIATION 11.81 |
| Sex: Female, Male Female | 98 Participants |
| Sex: Female, Male Male | 260 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 358 |
| serious Total, serious adverse events | 4 / 358 |
Outcome results
Primary
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Time frame: Maximum of 24 months.
Population: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 1 (n=163) | 4.37 milligrams/kilograms (mg/kg) | Standard Deviation 0.93 |
| Remicade | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 2 (n=164) | 4.39 milligrams/kilograms (mg/kg) | Standard Deviation 0.9 |
| Remicade | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 3 (n=164) | 4.43 milligrams/kilograms (mg/kg) | Standard Deviation 0.88 |
| Remicade | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 4 (n=165) | 4.42 milligrams/kilograms (mg/kg) | Standard Deviation 0.89 |
| Remicade | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 5 (n=165) | 4.44 milligrams/kilograms (mg/kg) | Standard Deviation 0.87 |
| Remicade | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 6 (n=160) | 4.47 milligrams/kilograms (mg/kg) | Standard Deviation 0.87 |
| Remicade | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 7 (n=154) | 4.54 milligrams/kilograms (mg/kg) | Standard Deviation 0.91 |
| Remicade | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 8 (n=152) | 4.59 milligrams/kilograms (mg/kg) | Standard Deviation 0.94 |
| Remicade | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 9 (n=143) | 4.67 milligrams/kilograms (mg/kg) | Standard Deviation 0.93 |
Primary
Mean Remicade Dose Per Participant
Time frame: Maximum of 24 months
Population: Remicade-naive participants who were exposed to Remicade during the observational study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remicade | Mean Remicade Dose Per Participant | 4.53 mg/kg | Standard Deviation 0.84 |
Primary
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Time frame: Maximum of 24 months
Population: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 3/4 (n=165) | 56.10 Days | Standard Deviation 10.97 |
| Remicade | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 4/5 (n=165) | 60.62 Days | Standard Deviation 25.58 |
| Remicade | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 5/6 (n=159) | 57.91 Days | Standard Deviation 8.11 |
| Remicade | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 6/7 (n=154) | 59.39 Days | Standard Deviation 15.91 |
| Remicade | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 7/8 (n=152) | 59.52 Days | Standard Deviation 17.67 |
| Remicade | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 8/9 (n=143) | 60.36 Days | Standard Deviation 17.96 |
Primary
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Time frame: Maximum of 24 months.
Population: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remicade | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 4 (n=165) | 4.62 mg/kg |
| Remicade | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 1 (n=163) | 4.60 mg/kg |
| Remicade | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 2 (n=164) | 4.62 mg/kg |
| Remicade | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 3 (n=164) | 4.62 mg/kg |
| Remicade | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 5 (n=165) | 4.62 mg/kg |
| Remicade | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 6 (n=160) | 4.66 mg/kg |
| Remicade | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 7 (n=154) | 4.68 mg/kg |
| Remicade | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 8 (n=152) | 4.71 mg/kg |
| Remicade | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Infusion 9 (n=143) | 4.71 mg/kg |
Primary
Median Remicade Dose Per Participant
Time frame: Maximum of 24 months
Population: Remicade-naive participants who were exposed to Remicade during the observational study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Remicade | Median Remicade Dose Per Participant | 4.75 mg/kg |
Primary
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Time frame: Maximum of 24 months
Population: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remicade | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 3/4 (n=165) | 57.00 Days |
| Remicade | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 4/5 (n=165) | 57.00 Days |
| Remicade | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 5/6 (n=159) | 57.00 Days |
| Remicade | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 6/7 (n=154) | 57.00 Days |
| Remicade | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 7/8 (n=152) | 57.00 Days |
| Remicade | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Infusion 8/9 (n=143) | 57.00 Days |