Trial Outcomes & Findings for Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-Naïve Disease (RESPOND) (Study P04422) (NCT NCT00367237)
NCT ID: NCT00367237
Last Updated: 2017-04-11
Results Overview
\>=20% improvement in swollen and tender joint count AND \>=20% improvement in 3 of the following: visual analog scale (VAS) assessment of pain; subject VAS global assessment of disease activity; evaluator VAS global assessment of disease activity; Health Assessment Questionnaire (HAQ) disability index; C-Reactive Protein (CRP) level.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
115 participants
Primary outcome timeframe
between baseline and week 16
Results posted on
2017-04-11
Participant Flow
115 subjects (57 infliximab (IFX) + MTX and 58 MTX), but only 110 subjects (56 and 54) were considered intent to treat (ITT). Furthermore, 99 subjects (51 + 48) were in a treatment group at Week 16 for Primary Endpoint evaluation.
Participant milestones
| Measure |
Infliximab + Methotrexate (IFX + MTX)
Remicade (infliximab \[IFX\]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
|
Methotrexate (MTX)
Oral methotrexate (MTX) 15 mg/week
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
58
|
|
Overall Study
COMPLETED
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
| Measure |
Infliximab + Methotrexate (IFX + MTX)
Remicade (infliximab \[IFX\]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
|
Methotrexate (MTX)
Oral methotrexate (MTX) 15 mg/week
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Protocol Violation
|
2
|
5
|
Baseline Characteristics
Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-Naïve Disease (RESPOND) (Study P04422)
Baseline characteristics by cohort
| Measure |
Infliximab + Methotrexate (IFX + MTX)
n=56 Participants
Remicade (infliximab \[IFX\]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
|
Methotrexate (MTX)
n=54 Participants
Oral methotrexate (MTX) 15 mg/week
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.1 years
n=5 Participants
|
42.3 years
n=7 Participants
|
41.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: between baseline and week 16Population: Number of subjects from Intent-to-Treat population in each arm at Week 16
\>=20% improvement in swollen and tender joint count AND \>=20% improvement in 3 of the following: visual analog scale (VAS) assessment of pain; subject VAS global assessment of disease activity; evaluator VAS global assessment of disease activity; Health Assessment Questionnaire (HAQ) disability index; C-Reactive Protein (CRP) level.
Outcome measures
| Measure |
Infliximab + Methotrexate (IFX + MTX)
n=51 Participants
Remicade (infliximab \[IFX\]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
|
Methotrexate (MTX)
n=48 Participants
Oral methotrexate (MTX) 15 mg/week
|
|---|---|---|
|
Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16
|
44 participants
|
32 participants
|
SECONDARY outcome
Timeframe: between baseline and week 16This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: between baseline and week 16This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: between baseline and week 16This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
Outcome measures
Outcome data not reported
Adverse Events
Infliximab + Methotrexate (IFX + MTX)
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Methotrexate (MTX)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infliximab + Methotrexate (IFX + MTX)
n=57 participants at risk
Remicade (infliximab \[IFX\]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
|
Methotrexate (MTX)
n=54 participants at risk
Oral methotrexate (MTX) 15 mg/week
|
|---|---|---|
|
General disorders
Infusion related reaction
|
1.8%
1/57 • Number of events 1
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
0.00%
0/54
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
|
Infections and infestations
Pulmonary Tuberculosis
|
1.8%
1/57 • Number of events 1
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
0.00%
0/54
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
Other adverse events
| Measure |
Infliximab + Methotrexate (IFX + MTX)
n=57 participants at risk
Remicade (infliximab \[IFX\]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
|
Methotrexate (MTX)
n=54 participants at risk
Oral methotrexate (MTX) 15 mg/week
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/57
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
5.6%
3/54 • Number of events 3
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
|
Investigations
Alanine Aminotransferase Increased
|
10.5%
6/57 • Number of events 6
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
9.3%
5/54 • Number of events 5
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
|
Investigations
Blood Bilirubin Increased
|
3.5%
2/57 • Number of events 2
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
5.6%
3/54 • Number of events 3
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
|
Investigations
Transaminases Increased
|
5.3%
3/57 • Number of events 4
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
1.9%
1/54 • Number of events 1
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
|
Nervous system disorders
Headache
|
5.3%
3/57 • Number of events 3
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
1.9%
1/54 • Number of events 2
Safety analyses included all subjects who received at least 1 dose of study medication Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator must provide 30 days written notice to sponsor prior to submission for publication/presentation, so that sponsor can review the material(s). If the parties disagree concerning the appropriateness of the material for publication, the investigator must meet with sponsor prior to publication/presentation, in order to make good faith efforts to discuss and resolve any disagreements.
- Publication restrictions are in place
Restriction type: OTHER