An interventional study of Remicade in Crohn's Disease, sponsored by Shradha Agarwal. Terminated at 1 site in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2014-04-09.
Sponsored by Shradha Agarwal · Not applicable and Interventional
The purpose of this study is to improve the investigators understanding of the relationship between Crohn's disease and blood levels of the drug infliximab (Remicade). The investigators want to determine whether measuring drug levels can be helpful in understanding how patients respond to this treatment.
The efficacy of infliximab to maintain remission in Crohn's disease has been confirmed by randomized, controlled trials, however the utility of serum infliximab and ATI titers is less clearly described in the clinical practice setting to manage dose and interval levels.
The primary objective of this study is to evaluate the clinical responsiveness of active (HBI >10) Crohn's disease to infliximab as it relates to serum infliximab levels. Though the assay for an infliximab level is commercially available, current dosing practices rely on the assessment of clinical data (laboratory data, symptoms, colonoscopy, etc). In order to understand this relationship, serum infliximab and ATI titers will be collected over the course of 8 (approximately 1 year) infusions. The results of these levels will be retrospectively correlated to the patient's clinical response to treatment.
The secondary objective is to identify predictors of poor response to infliximab by evaluating the efficacy of a dose escalation strategy in patients classified as primary or secondary non-responders.
Understanding the association of serum infliximab levels to disease response may be a useful objective tool to optimize and individualize dosing amount and frequency especially in patients with incomplete or loss of response to therapy.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's enrollment of 11 is below the median of 66 across 1,212 interventional studies indexed under Crohn Disease.
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Subjects will begin with receiving infliximab at 5 mg/kg for the first visits. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.
Drug: Remicade
The first potential for dose augmentation will be at infusion #3 (visit 1 and 2 patients will receive 5 mg/kg). Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.
Also known as: Dose escalation
Remicade Dose Escalation
At visit 1 and 2, Remicade given at 5mg/kg. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.
Time frame: 2/16/12-3/22/13
11 patients were recruited between 2/16/12 and 10/18/12. Patient were recruited either during inpatient hospitalization or outpatient visit for Remicade.
| Milestone | Remicade |
|---|---|
| Started | 11 |
| Completed | 3 |
| Not completed | 8 |
| Withdrew: Study terminated | 8 |
At visit 1 and 2, Remicade given at 5mg/kg. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.
| participants | Remicade |
|---|---|
| Remicade Dose Escalation | 5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Remicade | — | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(years) | Remicade |
|---|---|
| Mean | 34 (10 to 55) |
| Sex: Female, Male(Participants) | Remicade |
|---|---|
| Female | 5 |
| Male | 6 |
| Region of Enrollment(participants) | Remicade |
|---|---|
| United States | 11 |
This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Infliximab