A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.

Ulcerative Colitis Clinical Trial

Official title:

A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787202
• Other study ID #: A3921063
• Status: Completed
• Phase: Phase 2
• First received: November 6, 2008
• Last updated: March 6, 2013
• Start date: December 2008
• Est. completion date: September 2010

Study information

• Verified date: March 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be at least 18 years of age at screening

• Males and female patients with clinical diagnosis of ulcerative colitis =3 months prior to entry into the study.

• Male and female patients with active currently moderate to severe ulcerative colitis defined by Mayo score of =6

• Patients with endoscopic sub-score of =2 on the Mayo score determined within 7 days of baseline.

Exclusion Criteria:

• Diagnosis of Crohn's disease or diagnosis of indeterminate colitis

• Treatment naive subjects who have not had previous exposure to treatment for ulcerative colitis

• Patients that are currently receiving immunosuppressants, anti-TNFa therapy or interferon

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• CP- 690 550
Administration via oral route twice daily for the duration of treatment
• CP- 690 550
Administration via oral route twice daily for the duration of treatment
• CP- 690 550
Administration via oral route twice daily for the duration of treatment
• CP- 690 550
Administration via oral route twice daily for the duration of treatment

Other:
• placebo
Administration via oral route twice daily for the duration of treatment

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Antwerpen
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Leuven
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Chile	Pfizer Investigational Site	Independencia	Santiago RM
Chile	Pfizer Investigational Site	Independencia	Santiago
Chile	Pfizer Investigational Site	Vina del Mar
Czech Republic	Pfizer Investigational Site	Hradec Kralove
Czech Republic	Pfizer Investigational Site	Olomouc
Czech Republic	Pfizer Investigational Site	Usti n. Labem
Czech Republic	Pfizer Investigational Site	Usti nad Labem
Denmark	Pfizer Investigational Site	Aalborg
Denmark	Pfizer Investigational Site	Aarhus C
France	Pfizer Investigational Site	Bordeaux cedex
France	Pfizer Investigational Site	Lille Cedex
France	Pfizer Investigational Site	Marseille cedex 20
France	Pfizer Investigational Site	Nantes CEDEX 1
Hungary	Pfizer Investigational Site	Bekescsaba
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Debrecen
Hungary	Pfizer Investigational Site	Gyor
Hungary	Pfizer Investigational Site	Gyula
Hungary	Pfizer Investigational Site	Kaposvar
Hungary	Pfizer Investigational Site	Miskolc
Hungary	Pfizer Investigational Site	Mosonmagyarovar
Hungary	Pfizer Investigational Site	Szeged
Hungary	Pfizer Investigational Site	Szekszard
Hungary	Pfizer Investigational Site	Szentes
Israel	Pfizer Investigational Site	Haifa
Israel	Pfizer Investigational Site	Petah-tikva
Israel	Pfizer Investigational Site	Tel Aviv
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Roma
Mexico	Pfizer Investigational Site	Delegacion Benito Juarez	Mexico DF
Mexico	Pfizer Investigational Site	Tlalpan	Mexico DF
Netherlands	Pfizer Investigational Site	Amsterdam	NH
Poland	Pfizer Investigational Site	Bydgoszcz
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Wroclaw
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Nitra
South Africa	Pfizer Investigational Site	Claremont	Western Cape
South Africa	Pfizer Investigational Site	Durban	Kwa-Zulu Natal
South Africa	Pfizer Investigational Site	Durbanville	Western Cape
South Africa	Pfizer Investigational Site	Johannesburg	Gauteng
South Africa	Pfizer Investigational Site	Overport	Durban
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	L'hospitalet de Llobregat	Barcelona
Spain	Pfizer Investigational Site	Majadahonda	Madrid
Sweden	Pfizer Investigational Site	Umea
Sweden	Pfizer Investigational Site	Vaxjo
United Kingdom	Pfizer Investigational Site	Bristol
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  Brazil,  Chile,  Czech Republic,  Denmark,  France,  Hungary,  Israel,  Italy,  Mexico,  Netherlands,  Poland,  Slovakia,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Clinical Response	Clinical response was defined as a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with accompanying decrease in subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).	Week 8	No
Secondary	Percentage of Participants With Clinical Remission	Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score:instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).	Week 8	No
Secondary	Percentage of Participants With Endoscopic Response	Endoscopic response was defined as decrease from baseline in the findings of the flexible proctosigmoidoscopy subscore of the Mayo score at least 1 point. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).	Week 8	No
Secondary	Percentage of Participants With Endoscopic Remission	Endoscopic remission was defined as the findings of flexible proctosigmoidoscopy subscore of the Mayo score equals 0. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).	Week 8	No
Secondary	Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12	Partial Mayo score was ranged from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores: stool frequency, rectal bleeding and physician's global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).	Baseline, Week 2, 4, 8, 12	No
Secondary	Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8	IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicates better QOL. Positive change in total score indicated improvement in QOL.	Baseline, Week 8	No
Secondary	Change From Baseline in Level of C-Reactive Protein (CRP) at Week 4 and 8	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.	Baseline, Week 4, 8	No
Secondary	Change From Baseline in Level of Fecal Calprotectin at Week 2, 4, 8 and 12	Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.	Baseline, Week 2, 4, 8, 12	No
Secondary	Plasma Concentration of CP-690,550	Summary statistics were calculated for each dose group using the nominal collection times and by setting concentration values below the lower limit of quantification (LLOQ) (LLOQ=0.1 nanogram per milliliter [ng/mL]) to zero.	0.25, 0.5, 1, 2 hours post-dose on Day 1, 0 (pre-dose) and 1 hour post-dose on Week 2, Week 4, 0 (pre-dose), 0.25, 0.5, 1, 2 hours post-dose on Week 8	No

External Links

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