At present there are no validated parameters that predict how a patient will respond to inflixmab treatment.In this study they like to investigate why a certain persentige of patients do have a disease flaire. This suggests that infliximab levels in…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study eindpoint is the difference between the mean of the DAS28 in
each dose intensification arm as compared to the mean in the control arm. The
aim is to show that this differende between the means is at least 0.6.
Secondary outcome
Secondary study endpoints:
- Bone turnover as measured by urine CTX-II
- Percentage of patients who regain initial (w6) response
- Percentage of patients who drop out for (continued or new) flare
- EULAR response, ACR response week 14/22- week 38/46
- Other DAS28 cut-off scores for flare and response
- Quality of Life measuremment: RA-QOL
- Pharmaco-economic evaluation
- % of patients who need rescue medication
Background summary
Over 60% of rheumatoid arthritis (RA) patiens respon to induction of infliximab
treatment (infusion of 3 mg/kg at week 0, 2, 6) Within this group of responders
the majority of patients show a sustained response. In an estimated 15- 20% of
patients initiated, however, the response shown at week 6 is followed by a
disease flare when the patient is switched to one infusion every 8 weeks.
Study objective
At present there are no validated parameters that predict how a patient will
respond to inflixmab treatment.
In this study they like to investigate why a certain persentige of patients do
have a disease flaire. This suggests that infliximab levels in these patients
fall below a certain efficacy threshold.
Based on this, two approaches have been suggested so as to optimize treatment
for these patients.
Study design
The patients will be devided in three groups (by randomisation with the IVRS
system).
Randomisation groups:
1. Control: same stable dose 3mg/kg every 8 weeks;
2. Increased frequency: stable dose 3mg/kg every 6 weeks
3. Increased dose: one extra vial to previous dose; every 8 weeks.
The patients of the control group and the increased dose group (every 8 weeks)
are double-blind.
The patients who receive medication every 6 weeks are "open"
Intervention
Randomisation groups:
1. Control: same stable dose 3mg/kg every 8 weeks;
2. Increased frequency: stable dose 3mg/kg every 6 weeks
3. Increased dose: one extra vial to previous dose; every 8 weeks
Study burden and risks
The patient has 8 visits in a period of 24 weeks.
During the study al adverse events that the patient reports during the study
will be followed up and judged. The patient fills in at every visit a Health
Assessment Questionaire (HAQ) During visit 2,5 and the final visit a SF-36v2
will be filled in.
At every visit a DAS 28 score will be done. (VAS, laboratory assesments and
jointsscore).
Severe adverse events must be reported in 24 hours toward the sponsor and the
appropriate Institutional FEview Board or Independent Ethics Committee.
Maarsenbroeksedijk 4
3542DN Utrecht
Nederland
Maarsenbroeksedijk 4
3542DN Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Subject has RA according to ACR criteria
Subject aged 18 years or more
Subject received the standard Remicad dosing schedule as per the EU label: 3mg/kg weeks 0, 2 and 6 followed by 1 or 2 intervals of 8 weeks.
DAS 28 worsening of at least 0.6 between the time of initial response and the next 8 weekly infusion and the resulting DAS28 value
Exclusion criteria
pregnancy
Remicade allergy
patient didn't show an initial response on Remicade (infliximab) during the induction period.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2005-001889-13-NL |
| CCMO | NL11336.091.06 |