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

NCT00787202 | Completed Phase 2 Results

• 1 other identifier: A3921063
• Study Type: interventional
• Target: 195
• Locations: 17 countries
• Sites: 59

Brief 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.

Conditions

Ulcerative Colitis

Keywords

treatment of ulcerative colitis; CP 690 550

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Percentage of Participants With Clinical Remission

  Week 8

• Percentage of Participants With Endoscopic Response

  Week 8

• Percentage of Participants With Endoscopic Remission

  Week 8

• Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12

  Baseline, Week 2, 4, 8, 12

• Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8

  Baseline, Week 8

Study Arms (5)

15 mg BID

EXPERIMENTAL

Drug: CP- 690 550

10 mg BID

EXPERIMENTAL

Drug: CP- 690 550

3 mg BID

EXPERIMENTAL

Drug: CP- 690 550

0.5 mg BID

EXPERIMENTAL

Drug: CP- 690 550

Placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

CP- 690 550 DRUG

Administration via oral route twice daily for the duration of treatment

15 mg BID

placebo OTHER

Administration via oral route twice daily for the duration of treatment

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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-TNFα therapy or interferon

Sponsors & Collaborators

• Pfizer: lead

Study Sites (59)

Pfizer Investigational Site

Antwerp, 2020, Belgium

Location

Pfizer Investigational Site

Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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São Paulo, São Paulo, 01244-030, Brazil

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São Paulo, São Paulo, 05651-901, Brazil

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Independencia, Santiago Metropolitan, 8380418, Chile

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Independencia, Santiago RM, 8380456, Chile

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Viña del Mar, 2570017, Chile

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Hradec Králové, 50012, Czechia

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Olomouc, 775 20, Czechia

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Usti N. Labem, 401 13, Czechia

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Ústí nad Labem, 401 13, Czechia

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Aalborg, 9100, Denmark

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Aarhus C, 8000, Denmark

Location

Pfizer Investigational Site

Lille, France, 59037, France

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Bordeaux, 33075, France

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Marseille, 13915, France

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Nantes, 44093, France

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Békéscsaba, 5600, Hungary

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Budapest, 1125, Hungary

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Budapest, 1135, Hungary

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Debrecen, 4004, Hungary

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Győr, 9023, Hungary

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Gyula, 5701, Hungary

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Kaposvár, 7400, Hungary

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Miskolc, 3529, Hungary

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Mosonmagyaróvár, 9200, Hungary

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Szeged, 6720, Hungary

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Szekszárd, 7100, Hungary

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Pfizer Investigational Site

Szentes, 6600, Hungary

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Haifa, 31096, Israel

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Petah Tikva, 49100, Israel

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Tel Aviv, 64239, Israel

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Bologna, 40138, Italy

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Roma, 00152, Italy

Location

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Delegacion Benito Juarez, Mexico DF, 03300, Mexico

Location

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Tlalpan, Mexico DF, 14000, Mexico

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Amsterdam, North Holland, 1081 HV, Netherlands

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Bydgoszcz, 85-168, Poland

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Lodz, 90-153, Poland

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Wroclaw, 50-556, Poland

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Bratislava, Slovakia, 826 06, Slovakia

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Bratislava, 811 07, Slovakia

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Pfizer Investigational Site

Nitra, 94901, Slovakia

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Pfizer Investigational Site

Overport, Durban, 4091, South Africa

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Johannesburg, Gauteng, 2193, South Africa

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Durban, KwaZulu-Natal, 4001, South Africa

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Pfizer Investigational Site

Claremont, Western Cape, 7708, South Africa

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Durbanville, Western Cape, 7550, South Africa

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Barcelona, Barcelona, 08036, Spain

Location

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Pfizer Investigational Site

Majadahonda, Madrid, 28222, Spain

Location

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Umeå, 901 85, Sweden

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Vaxjo, 351 85, Sweden

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Pfizer Investigational Site

Bristol, BS2 8HW, United Kingdom

Location

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Glasgow, G11 6NT, United Kingdom

Location

Pfizer Investigational Site

Glasgow, G4 0SS, United Kingdom

Location

Pfizer Investigational Site

Manchester, M13 9WL, United Kingdom

Location

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• Mukherjee A, Tsuchiwata S, Nicholas T, Cook JA, Modesto I, Su C, D'Haens GR, Sandborn WJ. Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Clin Pharmacol Ther. 2022 Jul;112(1):90-100. doi: 10.1002/cpt.2601. Epub 2022 Apr 27.

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Limitations and Caveats

Pharmacokinetic (PK) parameters and their correlation with clinical response and inflammatory biomarkers were not reported as data from future studies were to be pooled for analysis.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 16, 2013
• Results First Posted: April 16, 2013

Record last verified: 2013-03

Locations

IL (3); ES (3); SE (2); DK (2); NL (1); IT (2); ZA (5); PL (3); BE (3); GB (4); SL (3); HU (12); CL (3); BR (3); FR (4); ME (2); CZ (4)