Primary: to assess the efficacy of GSK1605786A compared with placebo in maintaining remission. Secondary: Safety, quality of life, healthcare resource utilisation, work productivity.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of subjects in clinical remission (CDAI score <150 points) at both
Weeks 28 and 52 of the 52-week treatment period.
Secondary outcome
E.g. CDAI score <150 points in patients not taking corticosteroids at both
Weeks 28 and 52, clinical remission in week 52, change from baseline in CDAI at
various time points, IBDQ score, safety, quality of life, healthcare related
resource utilisation.
Background summary
GSK1605786A is an orally-administered chemokine antagonist which specifically
blocks the migration of gut-specific T cells, which selectively home to the
intestine.
Crohn*s disease is a chronic, idiopathic, relapsing inflammatory disorder of
the gastrointestinal tract associated with a dysregulated activation of immune
cell function. It can affect any portion of the gastrointestinal tract but most
commonly affects the terminal small intestine and colon with patients
experiencing considerable lifestyle disruption and disability including
diarrhoea, abdominal pain, malnutrition and anaemia. Currently there is no
curative medical therapy and patients may require treatment for life.
The purpose of this Phase III study is to investigate the efficacy and safety
of two doses of GSK1605786A (500 mg once or twice daily) administered orally
for 52 weeks as compared with placebo in maintaining remission in subjects with
moderately-to-severely active Crohn*s disease. Subjects enrolled in this study
will have previously achieved clinical response (CDAI decrease >=100 points)
and/or remission (CDAI < 150) in a Phase III induction study (Study CCX114151).
Study objective
Primary: to assess the efficacy of GSK1605786A compared with placebo in
maintaining remission. Secondary: Safety, quality of life, healthcare resource
utilisation, work productivity.
Study design
Multicenter randomized double blind phase III parallel group study.
Randomisation (1:1) to treatment with:
1. GSK1605786A 500 mg once daily.
2. GSK1605786A 500 mg twice daily.
3. Placebo.
Treatment allocation independent of the treatment group in the previous study
CCX114151.
Plus background therapy (not part of study treatment, on prescription.
Treatment duration 52 weeks.
Approx 750 patients for screening.
Intervention
Treatment with GSK1605786A or placebo.
Study burden and risks
Risk: Adverse effects of study medication.
Burden: 18 visits in 52 weeks. Duration 0,5-4 h.
Blood tests 18x (approx.120 ml in total), 6 PK samples at different timepoints
(during 1 visit or divided over several visits), pregnancy test (if relevant)
10x, ECG 4x. Questionnaires (EQ 5D, SF-36, IBDQ,WPI-CD) 3x.
Daily phone call to answer some questions about the abdominal symtoms during
the 8 days preceding 9 visits Time consumption 5 min/day.
Huis ter Heideweg 62
3705 LZ Zeist
NL
Huis ter Heideweg 62
3705 LZ Zeist
NL
Listed location countries
Age
Inclusion criteria
• Subjects achieving clinical response (CDAI decrease >= 100points) and/or remission (CDAI <150) upon completion of treatment in Study CCX114151.
• Safe contraception for women of childbearing potential.
• Any medications being currently received for Crohn*s disease must remain stable throughout the study period with the exception of tapering of corticosteroids.
• Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose tapering
Exclusion criteria
• Breastfeeding, pregnancy.
• Known coeliac disease, those who follow a gluten-free diet to manage symptoms of suspected coeliac disease and subjects with a positive screening test for celiac disease.
• Known or suspected small bowel stricture
• Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study 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 |
|---|---|
| Other | clinicaltrials.gov, registratienummer n.n.b. |
| EudraCT | EUCTR2010-022383-12-NL |
| CCMO | NL34540.018.10 |