A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease

A Phase 2 study testing CP-690,550 in people with Crohn's Disease, run by Pfizer at 72 sites in 12 countries.

Completed

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

Trial summary

This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Crohn's Disease
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: 139 participants
Where: 72 sitesin 12 countries
Study dates: Jan 2008to Oct 2009
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

Subjects must be at least 18 years of age at screening
Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
Subjects with moderate to severe Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive

Who cannot join

Subjects currently receiving immunosuppressants, interferon, anti-TNFa
Subjects with evidence of hematopoietic disorders
Subjects with evidence of active or latent TB

Trial locations and contacts

72 sites in 12 countries.

Country

City, postcode or hospital

72 sites in 12 countries

United States39 sites

Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Boca Raton, Florida, 33428
Pfizer Investigational Site
Boca Raton, Florida, 33442
Pfizer Investigational Site
Boca Raton, Florida, 33486
Pfizer Investigational Site
Boca Raton, Florida, 33496
Pfizer Investigational Site
Boulder, Colorado, 80304
Pfizer Investigational Site
Bristol, Tennessee, 37620
Pfizer Investigational Site
Charleston, West Virginia, 25304
Pfizer Investigational Site
Charlotte, North Carolina, 28209
Pfizer Investigational Site
Charlotte, North Carolina, 28210
Pfizer Investigational Site
Charlotte, North Carolina, 28211
Pfizer Investigational Site
Chevy Chase, Maryland, 20815
Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
Dallas, Texas, 75390-8887
Pfizer Investigational Site
Dayton, Ohio, 45415
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
Gainesville, Florida, 32605
Pfizer Investigational Site
Gainesville, Florida, 32607
Pfizer Investigational Site
Great Neck, New York, 11021
Pfizer Investigational Site
Jacksonville, Florida, 32207
Pfizer Investigational Site
Jacksonville, Florida, 32256
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Lakewood, Colorado, 80215
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Mexico, Missouri, 65265
Pfizer Investigational Site
Mobile, Alabama, 36617
Pfizer Investigational Site
Nashville, Tennessee, 37205
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15243
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
Salisbury, North Carolina, 28144
Pfizer Investigational Site
Seattle, Washington, 98195
Pfizer Investigational Site
St. Petersburg, Florida, 33709
Pfizer Investigational Site
Towson, Maryland, 21204
Pfizer Investigational Site
Troy, Michigan, 48098
Pfizer Investigational Site
Upper Saint Clair, Pennsylvania, 15241
Pfizer Investigational Site
Washington D.C., District of Columbia, 20006
Pfizer Investigational Site
Wheat Ridge, Colorado, 80033
Pfizer Investigational Site
Wichita, Kansas, 67208

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Hungary6 sites

Pfizer Investigational Site
Békéscsaba, 5600
Pfizer Investigational Site
Debrecen, 4004
Pfizer Investigational Site
Győr, 9023
Pfizer Investigational Site
Gyula, 5701
Pfizer Investigational Site
Kaposvár, 7400
Pfizer Investigational Site
Szekszárd, 7100

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South Africa5 sites

Pfizer Investigational Site
Cape Town, Western Cape, 7708
Pfizer Investigational Site
Durban, KwaZulu-Natal, 4001
Pfizer Investigational Site
Durban, South Africa, 4091
Pfizer Investigational Site
Durbanvilee, Cape Town
Pfizer Investigational Site
Johannesburg, Gauteng, 2193

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Belgium3 sites

Pfizer Investigational Site
Brussels, 1200
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Leuven, 3000

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France3 sites

Pfizer Investigational Site
Lille, 59037
Pfizer Investigational Site
Pessac, 33604
Pfizer Investigational Site
Vandœuvre-lès-Nancy, France, 54511

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Poland3 sites

Pfizer Investigational Site
Lublin, 20-954
Pfizer Investigational Site
Olsztyn, 10-561
Pfizer Investigational Site
Wroclaw, 50-556

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Slovakia3 sites

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

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Spain3 sites

Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
Pfizer Investigational Site
Majadahonda, Madrid, 28922

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Czechia2 sites

Pfizer Investigational Site
Hradec Králové, 50012
Pfizer Investigational Site
Ústí nad Labem, 401 13

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Italy2 sites

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

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United Kingdom2 sites

Pfizer Investigational Site
Bristol, BS2 8HW
Pfizer Investigational Site
Salford, M6 8HD

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Netherlands1 site

Pfizer Investigational Site
Amsterdam, 1105 AZ

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About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Investigate The Safety And Efficacy Of CP-690,550 In Subjects With Moderate To Severe Crohn's Disease.

Conditions: Crohn's Disease
Being tested: CP-690,550, Placebo
Medical subject headings: Crohn Disease

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
CP-690,550Drug
administration via oral route twice daily
CP-690,550Drug
administration via oral route twice daily
PlaceboDrug
administration via oral route twice daily

Study groups in NCT00615199
Study group	Role	What they receive
1mg BD	Experimental	Not described Receives: Drug: CP-690,550
5mg BD	Experimental	Not described Receives: Drug: CP-690,550
15mg BD	Experimental	Not described Receives: Drug: CP-690,550
Placebo BID	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Number of Participants With Clinical Response 70 at Week 4
Clinical response 70: defined as a reduction in Crohn's Disease Activity Index (CDAI) score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Measured: Week 4

Secondary outcomes (6)

Number of Participants With Clinical Response 70 at Week 1 and 2
Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Measured: Week 1, 2
Number of Participants Achieving Clinical Remission at Week 4
Clinical remission=CDAI at Week 4 less than (<) 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Measured: Week 4
Number of Participants With Clinical Response 100 at Week 4
Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Measured: Week 4
Time to First Clinical Remission
Clinical remission=CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Measured: Week 1 through Week 4
Time to First Response 70
Clinical response 70: defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 , higher score indicates higher disease activity.
Measured: Week 1 through Week 4
Time to First Response 100
Clinical response 100: defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
Measured: Week 1 through Week 4

Timeline

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

Jan 2008Oct 2009

First posted14 Feb 2008 (estimated)
Study startJan 2008
Primary completionOct 2009
Study completionOct 2009

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 (2)Papers the sponsor has linked to this study.
Other trials for Crohn's DiseaseStudies 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: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00615199
Sponsor's protocol ID: A3921043
Status last verified: Jan 2013
First submitted: 14 Jan 2008
Last updated: 25 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sandborn WJ, Ghosh S, Panes J, Vranic I, Wang W, Niezychowski W; Study A3921043 Investigators. A phase 2 study of tofacitinib, an oral Janus kinase inhibitor, in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1485-93.e2. doi: 10.1016/j.cgh.2014.01.029. Epub 2014 Jan 27.
PubMed 24480677
Ghoreschi K, Jesson MI, Li X, Lee JL, Ghosh S, Alsup JW, Warner JD, Tanaka M, Steward-Tharp SM, Gadina M, Thomas CJ, Minnerly JC, Storer CE, LaBranche TP, Radi ZA, Dowty ME, Head RD, Meyer DM, Kishore N, O'Shea JJ. Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550). J Immunol. 2011 Apr 1;186(7):4234-43. doi: 10.4049/jimmunol.1003668. Epub 2011 Mar 7.
PubMed 21383241

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Investigate The Safety And Efficacy Of CP-690,550 In Subjects With Moderate To Severe Crohn's Disease.
ClinicalTrials.gov ID: NCT00615199
Acronym / sponsor ID: A3921043
Conditions: Crohn's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 14 Feb 2008 (estimated)
Results: Posted 31 Dec 2012

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1mg BD	Experimental	Drug: CP-690,550
5mg BD	Experimental	Drug: CP-690,550
15mg BD	Experimental	Drug: CP-690,550
Placebo BID	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (3 listed)

Subjects must be at least 18 years of age at screening
Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
Subjects with moderate to severe Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive

Key exclusion criteria (3 listed)

Subjects currently receiving immunosuppressants, interferon, anti-TNFa
Subjects with evidence of hematopoietic disorders
Subjects with evidence of active or latent TB

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	Drug	1mg BD
CP-690,550administration via oral route twice daily	Drug	5mg BD
CP-690,550administration via oral route twice daily	Drug	15mg BD
Placeboadministration via oral route twice daily	Drug	Placebo BID

Primary outcome

Number of Participants With Clinical Response 70 at Week 4
Time frame: Week 4
Clinical response 70: defined as a reduction in Crohn's Disease Activity Index (CDAI) score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.

6 secondary outcomes

Number of Participants With Clinical Response 70 at Week 1 and 2
Time frame: Week 1, 2
Number of Participants Achieving Clinical Remission at Week 4
Time frame: Week 4
Number of Participants With Clinical Response 100 at Week 4
Time frame: Week 4
Time to First Clinical Remission
Time frame: Week 1 through Week 4
Time to First Response 70
Time frame: Week 1 through Week 4
Time to First Response 100
Time frame: Week 1 through Week 4

Results and safety

Results posted to the registry on 31 Dec 2012, 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	34	26
CP-690550 1 mg	36	34
CP-690550 5 mg	34	33
CP-690550 15 mg	35	33

Primary outcome: Number of Participants With Clinical Response 70 at Week 4

Time frame: Week 4. Number. Unit: participants

Measure	Placebo n = 32	CP-690550 1 mg n = 35	CP-690550 5 mg n = 30	CP-690550 15 mg n = 33
Value	14	13	18	16

Population analysed: Full Analysis Set (FAS): all randomized participants who had either withdrawn as treatment failure or completed at least 1 week of dosing and had at least 1 valid CDAI score during the active double-blind phase. Number of participants analyzed excluded those with missing data or who fell outside the visit window.

6 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	5 of 34 (14.7%)	20 of 34 (58.8%)	Not reported
CP-690550 1 mg	4 of 36 (11.1%)	18 of 36 (50%)	Not reported
CP-690550 5 mg	4 of 34 (11.8%)	19 of 34 (55.9%)	Not reported
CP-690550 15 mg	1 of 35 (2.9%)	22 of 35 (62.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24480677Sandborn WJ, Ghosh S, Panes J, Vranic I, Wang W, Niezychowski W; Study A3921043 Investigators. A phase 2 study of tofacitinib, an oral Janus kinase inhibitor, in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1485-93.e2. doi: 10.1016/j.cgh.2014.01.029. Epub 2014 Jan 27.
Derived from this study: PubMed 21383241Ghoreschi K, Jesson MI, Li X, Lee JL, Ghosh S, Alsup JW, Warner JD, Tanaka M, Steward-Tharp SM, Gadina M, Thomas CJ, Minnerly JC, Storer CE, LaBranche TP, Radi ZA, Dowty ME, Head RD, Meyer DM, Kishore N, O'Shea JJ. Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550). J Immunol. 2011 Apr 1;186(7):4234-43. doi: 10.4049/jimmunol.1003668. Epub 2011 Mar 7.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Crohn's Disease

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RecruitingObservational study
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Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
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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

72 sites in 12 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 Crohn's Disease, run by Pfizer at 72 sites in 12 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 3 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 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Hungary, South Africa, Belgium, France and 7 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 31 Dec 2012). 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?

Number of Participants With Clinical Response 70 at Week 4 (time frame: Week 4). 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 NCT00615199, which also lists 2 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 25 Jan 2013.