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

A Phase 2 study testing CP- 690 550 in people with Ulcerative Colitis, run by Pfizer at 59 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ulcerative Colitis
What is being tested?: CP- 690 550
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 195 participants
Where: 59 sitesin 17 countries
Study dates: Dec 2008to Sep 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

59 sites in 17 countries.

Country

City, postcode or hospital

59 sites in 17 countries

Hungary12 sites

Pfizer Investigational Site
Békéscsaba, 5600
Pfizer Investigational Site
Budapest, 1125
Pfizer Investigational Site
Budapest, 1135
Pfizer Investigational Site
Debrecen, 4004
Pfizer Investigational Site
Győr, 9023
Pfizer Investigational Site
Gyula, 5701
Pfizer Investigational Site
Kaposvár, 7400
Pfizer Investigational Site
Miskolc, 3529
Pfizer Investigational Site
Mosonmagyaróvár, 9200
Pfizer Investigational Site
Szeged, 6720
Pfizer Investigational Site
Szekszárd, 7100
Pfizer Investigational Site
Szentes, 6600

Other trials in Hungary

South Africa5 sites

Pfizer Investigational Site
Claremont, Western Cape, 7708
Pfizer Investigational Site
Durban, KwaZulu-Natal, 4001
Pfizer Investigational Site
Durbanville, Western Cape, 7550
Pfizer Investigational Site
Johannesburg, Gauteng, 2193
Pfizer Investigational Site
Overport, Durban, 4091

Other trials in South Africa

Czechia4 sites

Pfizer Investigational Site
Hradec Králové, 50012
Pfizer Investigational Site
Olomouc, 775 20
Pfizer Investigational Site
Usti N. Labem, 401 13
Pfizer Investigational Site
Ústí nad Labem, 401 13

Other trials in Czechia

France4 sites

Pfizer Investigational Site
Bordeaux, 33075
Pfizer Investigational Site
Lille, France, 59037
Pfizer Investigational Site
Marseille, 13915
Pfizer Investigational Site
Nantes, 44093

Other trials in France

United Kingdom4 sites

Pfizer Investigational Site
Bristol, BS2 8HW
Pfizer Investigational Site
Glasgow, G11 6NT
Pfizer Investigational Site
Glasgow, G4 0SS
Pfizer Investigational Site
Manchester, M13 9WL

Other trials in United Kingdom

Belgium3 sites

Pfizer Investigational Site
Antwerp, 2020
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Leuven, 3000

Other trials in Belgium

Brazil3 sites

Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000
Pfizer Investigational Site
São Paulo, São Paulo, 01244-030
Pfizer Investigational Site
São Paulo, São Paulo, 05651-901

Other trials in Brazil

Chile3 sites

Pfizer Investigational Site
Independencia, Santiago Metropolitan, 8380418
Pfizer Investigational Site
Independencia, Santiago RM, 8380456
Pfizer Investigational Site
Viña del Mar, 2570017

Other trials in Chile

Israel3 sites

Pfizer Investigational Site
Haifa, 31096
Pfizer Investigational Site
Petah Tikva, 49100
Pfizer Investigational Site
Tel Aviv, 64239

Other trials in Israel

Poland3 sites

Pfizer Investigational Site
Bydgoszcz, 85-168
Pfizer Investigational Site
Lodz, 90-153
Pfizer Investigational Site
Wroclaw, 50-556

Other trials in Poland

Slovakia3 sites

Pfizer Investigational Site
Bratislava, Slovakia, 826 06
Pfizer Investigational Site
Bratislava, 811 07
Pfizer Investigational Site
Nitra, 94901

Other trials in Slovakia

Spain3 sites

Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
Pfizer Investigational Site
Majadahonda, Madrid, 28222

Other trials in Spain

Denmark2 sites

Pfizer Investigational Site
Aalborg, 9100
Pfizer Investigational Site
Aarhus C, 8000

Other trials in Denmark

Italy2 sites

Pfizer Investigational Site
Bologna, 40138
Pfizer Investigational Site
Roma, 00152

Other trials in Italy

Mexico2 sites

Pfizer Investigational Site
Delegacion Benito Juarez, Mexico DF, 03300
Pfizer Investigational Site
Tlalpan, Mexico DF, 14000

Other trials in Mexico

Sweden2 sites

Pfizer Investigational Site
Umeå, 901 85
Pfizer Investigational Site
Vaxjo, 351 85

Other trials in Sweden

Netherlands1 site

Pfizer Investigational Site
Amsterdam, North Holland, 1081 HV

Other trials in Netherlands

About this study

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.

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
Being tested: CP- 690 550, placebo
Keywords: treatment of ulcerative colitis; CP 690 550
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00787202
Study group	Role	What they receive
15 mg BID	Experimental	Not described Receives: Drug: CP- 690 550
10 mg BID	Experimental	Not described Receives: Drug: CP- 690 550
3 mg BID	Experimental	Not described Receives: Drug: CP- 690 550
0.5 mg BID	Experimental	Not described Receives: Drug: CP- 690 550
Placebo	Placebo comparator	Not described Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Week 8

Secondary outcomes (8)

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).
Measured: Week 8
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).
Measured: Week 8
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).
Measured: Week 8
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).
Measured: Baseline, Week 2, 4, 8, 12
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.
Measured: Baseline, Week 8
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.
Measured: Baseline, Week 4, 8
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.
Measured: Baseline, Week 2, 4, 8, 12
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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Sep 2010

First posted7 Nov 2008 (estimated)
Study startDec 2008
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 195 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00787202
Sponsor's protocol ID: A3921063
Status last verified: Mar 2013
First submitted: 6 Nov 2008
Last updated: 16 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.
PubMed 36931693
Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.
PubMed 36526796
Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):27-41. doi: 10.1093/ibd/izac084.
PubMed 36342120
Sandborn WJ, D'Haens GR, Sands BE, Panaccione R, Ng SC, Lawendy N, Kulisek N, Modesto I, Guo X, Mundayat R, Su C, Vranic I, Panes J. Tofacitinib for the Treatment of Ulcerative Colitis: An Integrated Summary of up to 7.8 Years of Safety Data from the Global Clinical Programme. J Crohns Colitis. 2023 Apr 3;17(3):338-351. doi: 10.1093/ecco-jcc/jjac141.
PubMed 36124702
Loftus EV, Baumgart DC, Gecse K, Kinnucan JA, Connelly SB, Salese L, Su C, Kwok KK, Woolcott JC, Armuzzi A. Clostridium difficile Infection in Patients with Ulcerative Colitis Treated with Tofacitinib in the Ulcerative Colitis Program. Inflamm Bowel Dis. 2023 May 2;29(5):744-751. doi: 10.1093/ibd/izac139.
PubMed 35792493
Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.
PubMed 35648151
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.
PubMed 35380740
Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):51-61. doi: 10.1093/ibd/izac061.
PubMed 35380664
Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.
PubMed 33684552
Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.
PubMed 33513294
Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1821-1830.e3. doi: 10.1016/j.cgh.2020.10.038. Epub 2020 Oct 27.
PubMed 33127596
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
PubMed 32816215
Sandborn WJ, Panes J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.
PubMed 31599001
Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.
PubMed 31077827
Sandborn WJ, Panes J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.
PubMed 30476584

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00787202
Acronym / sponsor ID: A3921063
Conditions: Ulcerative Colitis
Keywords: treatment of ulcerative colitis; CP 690 550
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 195 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 7 Nov 2008 (estimated)
Results: Posted 16 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CP- 690 550Administration via oral route twice daily for the duration of treatment	Drug	15 mg BID
CP- 690 550Administration via oral route twice daily for the duration of treatment	Drug	10 mg BID
CP- 690 550Administration via oral route twice daily for the duration of treatment	Drug	3 mg BID
CP- 690 550Administration via oral route twice daily for the duration of treatment	Drug	0.5 mg BID
placeboAdministration via oral route twice daily for the duration of treatment	Other	Placebo

Primary outcome

Percentage of Participants With Clinical Response
Time frame: Week 8
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).

8 secondary outcomes

Percentage of Participants With Clinical Remission
Time frame: Week 8
Percentage of Participants With Endoscopic Response
Time frame: Week 8
Percentage of Participants With Endoscopic Remission
Time frame: Week 8
Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12
Time frame: Baseline, Week 2, 4, 8, 12
Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Level of C-Reactive Protein (CRP) at Week 4 and 8
Time frame: Baseline, Week 4, 8
Change From Baseline in Level of Fecal Calprotectin at Week 2, 4, 8 and 12
Time frame: Baseline, Week 2, 4, 8, 12
Plasma Concentration of CP-690,550
Time frame: 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

Results and safety

Results posted to the registry on 16 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	49	35
CP-690,550 0.5 mg	31	20
CP-690,550 3 mg	33	26
CP-690,550 10 mg	33	31
CP-690,550 15 mg	49	45

Primary outcome: Percentage of Participants With Clinical Response

Time frame: Week 8. Number. Unit: percentage of participants

Measure	Placebo n = 40	CP-690,550 0.5 mg n = 27	CP-690,550 3 mg n = 31	CP-690,550 10 mg n = 30	CP-690,550 15 mg n = 45
Value	47.5	29.6	51.6	63.3	80.0

Population analysed: Full analysis set (FAS): all participants who withdrew as treatment failure (TF) or completed \>=1 week dosing, had \>=1 valid Mayo score during active double-blind phase. Participants who withdrew as TF=non-responders. Missing data due to reason other than TF were excluded. N (number of participants analyzed)=evaluable participants for the measure.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 48 (8.3%)	21 of 48 (43.8%)	Not reported
CP-690,550 0.5 mg	1 of 31 (3.2%)	19 of 31 (61.3%)	Not reported
CP-690,550 3 mg	1 of 33 (3%)	10 of 33 (30.3%)	Not reported
CP-690,550 10 mg	2 of 33 (6.1%)	13 of 33 (39.4%)	Not reported
CP-690,550 15 mg	2 of 49 (4.1%)	20 of 49 (40.8%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36931693Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.
Derived from this study: PubMed 36526796Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.
Derived from this study: PubMed 36342120Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):27-41. doi: 10.1093/ibd/izac084.
Derived from this study: PubMed 36124702Sandborn WJ, D'Haens GR, Sands BE, Panaccione R, Ng SC, Lawendy N, Kulisek N, Modesto I, Guo X, Mundayat R, Su C, Vranic I, Panes J. Tofacitinib for the Treatment of Ulcerative Colitis: An Integrated Summary of up to 7.8 Years of Safety Data from the Global Clinical Programme. J Crohns Colitis. 2023 Apr 3;17(3):338-351. doi: 10.1093/ecco-jcc/jjac141.
Derived from this study: PubMed 35792493Loftus EV, Baumgart DC, Gecse K, Kinnucan JA, Connelly SB, Salese L, Su C, Kwok KK, Woolcott JC, Armuzzi A. Clostridium difficile Infection in Patients with Ulcerative Colitis Treated with Tofacitinib in the Ulcerative Colitis Program. Inflamm Bowel Dis. 2023 May 2;29(5):744-751. doi: 10.1093/ibd/izac139.
Derived from this study: PubMed 35648151Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.
Derived from this study: PubMed 35380740Mukherjee 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.
Derived from this study: PubMed 35380664Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):51-61. doi: 10.1093/ibd/izac061.
Derived from this study: PubMed 33684552Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.
Derived from this study: PubMed 33513294Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.
Derived from this study: PubMed 33127596Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1821-1830.e3. doi: 10.1016/j.cgh.2020.10.038. Epub 2020 Oct 27.
Derived from this study: PubMed 32816215Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

59 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CP- 690 550 in people with Ulcerative Colitis, run by Pfizer at 59 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in Hungary, South Africa, Czechia, France, United Kingdom and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Clinical Response (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00787202, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2013.