Arthritis, RheumatoidNCT00414661

Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550

An observational study of Arthritis, Rheumatoid, run by Pfizer at 72 sites in 21 countries.

Completed

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

Trial summary

The purpose of this study is to follow the health of subjects who have previously been enrolled in studies of CP-690,550 for treatment of their rheumatoid arthritis. Subjects are only eligible for this study after they have completed all participation in other studies of CP-690,550. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthritis, Rheumatoid
What is being tested?: CP-690,550
How many people: 162 participants
Where: 72 sitesin 21 countries
Study dates: Apr 2007to Feb 2012
Phase: Observational
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

Study population: Subjects who have received at least one dose of study drug and ceased participation in any Phase 2B or 3 randomized, controlled or open-label (qualifying) study of CP-690,550 for the treatment of RA, but are no longer receiving CP-690,550.

Who may be able to join

Subjects who have completed all participation in any other Phase 2B or Phase 3 studies of CP-690,550 for rheumatoid arthritis.

Who cannot join

Any subject who refuses consent.

Trial locations and contacts

72 sites in 21 countries.

Country

City, postcode or hospital

72 sites in 21 countries

United States21 sites

Pfizer Investigational Site
Albany, New York, 12206-1043
Pfizer Investigational Site
Gilbert, Arizona, 85234
Pfizer Investigational Site
Hickory, North Carolina, 28601
Pfizer Investigational Site
Hickory, North Carolina, 28602
Pfizer Investigational Site
Lincoln, Nebraska, 68516
Pfizer Investigational Site
Mesquite, Texas, 75150
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Orlando, Florida, 32804
Pfizer Investigational Site
Palo Alto, California, 94304
Pfizer Investigational Site
Rockford, Illinois, 61107
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
Sarasota, Florida, 34233
Pfizer Investigational Site
Stanford, California, 94305
Pfizer Investigational Site
Tacoma, Washington, 98405-2308
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Tampa, Florida, 33613
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
Tucson, Arizona, 85704
Pfizer Investigational Site
Upland, California, 91786
Pfizer Investigational Site
Venice, Florida, 34292
Pfizer Investigational Site
Wyomissing, Pennsylvania, 19610

Other trials in United States

South Korea6 sites

Pfizer Investigational Site
Daejeon, 302-799
Pfizer Investigational Site
Gwangju, 501-757
Pfizer Investigational Site
Incheon, 400-711
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 120-752
Pfizer Investigational Site
Seoul, 133-792

Other trials in South Korea

Czechia5 sites

Pfizer Investigational Site
Brno, 656 91
Pfizer Investigational Site
České Budějovice, 370 01
Pfizer Investigational Site
Prague, 128 50
Pfizer Investigational Site
Prague, 140 00
Pfizer Investigational Site
Praha 11 - Chodov, 148 00

Other trials in Czechia

Poland5 sites

Pfizer Investigational Site
Bialystok, 15-950
Pfizer Investigational Site
Poznan, 60-773
Pfizer Investigational Site
Sopot, 81-759
Pfizer Investigational Site
Warsaw, 02-256
Pfizer Investigational Site
Wroclaw, 50-088

Other trials in Poland

Brazil4 sites

Pfizer Investigational Site
Goiânia, Goiás, 74110-120
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 22271-100
Pfizer Investigational Site
São Paulo, São Paulo, 01323-903
Pfizer Investigational Site
São Paulo, São Paulo, 04266-010

Other trials in Brazil

Japan4 sites

Pfizer Investigational Site
Higashihiroshima, Hiroshima
Pfizer Investigational Site
Kitakyushu, Fukuoka
Pfizer Investigational Site
Sagamihara, Kanagawa
Pfizer Investigational Site
Shinjyuku-ku, Tokyo

Other trials in Japan

Chile3 sites

Pfizer Investigational Site
Providencia, Santiago, RM, 7500710
Pfizer Investigational Site
Santiago, RM, 7500922
Pfizer Investigational Site
Santiago, RM, 7501126

Other trials in Chile

Hungary3 sites

Pfizer Investigational Site
Budapest, H-1036
Pfizer Investigational Site
Szolnok, H-5000
Pfizer Investigational Site
Veszprém, H-8200

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India3 sites

Pfizer Investigational Site
Ahmedabad, Gujarat, 380 015
Pfizer Investigational Site
Mangalore, Karnataka, 575 001
Pfizer Investigational Site
Pune, Maharashtra, 411 001

Other trials in India

Slovakia3 sites

Pfizer Investigational Site
Bratislava, 81109
Pfizer Investigational Site
Piešťany, 921 01
Pfizer Investigational Site
Žilina, 012 07

Other trials in Slovakia

Argentina2 sites

Pfizer Investigational Site
Buenos Aires, C1034ACO
Pfizer Investigational Site
Buenos Aires, C1114AAH

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Greece2 sites

Pfizer Investigational Site
Athens, Goudi, 11527
Pfizer Investigational Site
Thessaloniki, 54 636

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Italy2 sites

Pfizer Investigational Site
Florence, 50139
Pfizer Investigational Site
Genova, 16132

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Mexico2 sites

Pfizer Investigational Site
México, D.f., 06726
Pfizer Investigational Site
Mexico City, Mexico City, 14000

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Bulgaria1 site

Pfizer Investigational Site
Sofia, 1612

Other trials in Bulgaria

Canada1 site

Pfizer Investigational Site
Victoria, British Columbia, V8V 3P9

Other trials in Canada

Dominican Republic1 site

Pfizer Investigational Site
Santo Domingo, Santo Domingo Province, 00000

Other trials in Dominican Republic

Finland1 site

Pfizer Investigational Site
Hyvinkää, 05800

Other trials in Finland

Puerto Rico1 site

Pfizer Investigational Site
San Juan, 00918

Other trials in Puerto Rico

Spain1 site

Pfizer Investigational Site
Guadalajara, Guadalajara, 19002

Other trials in Spain

Ukraine1 site

Pfizer Investigational Site
Vinnitsa, 21018

Other trials in Ukraine

About this study

Official title: A Prospective Observational Study To Evaluate Long-Term Safety And Functional Status Of Subjects With Rheumatoid Arthritis Previously Enrolled In Studies Of CP-690,550

Read the detailed description

At their last visit of a qualifying study, eligible subjects will be given the opportunity to participate in this study.

Conditions: Arthritis, Rheumatoid
Being tested: CP-690,550
Keywords: Observational non-interventional long-term safety
Medical subject headings: Arthritis, Rheumatoid

What participants receive

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

CP-690,550Drug
Subjects had to have received CP-690,550 or other blinded study drug in index study. No intervention in this long-term follow-up trial.

Study groups in NCT00414661
Study group	Role	What they receive
Study group		All enrolled subjects Receives: Drug: CP-690,550

What is being measured

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

Incidence of Lymphoproliferative Disorders (LPD)
Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with LPD by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.
Measured: Up to Month 24
Incidence of Lymphoma
Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with lymphoma by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.
Measured: Up to Month 24
Incidence of Important Infections
Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with important infections by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.
Measured: Up to Month 24

Timeline

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

Apr 2007Feb 2012

First posted21 Dec 2006 (estimated)
Study startApr 2007
Primary completionFeb 2012
Study completionFeb 2012

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.
Other trials for Arthritis, RheumatoidStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00414661
Sponsor's protocol ID: A3921029
Status last verified: Nov 2012
First submitted: 19 Dec 2006
Last updated: 1 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 of PTC844 in Participants With Active Rheumatoid Arthritis
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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Arthritis, Rheumatoid trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Observational Study To Evaluate Long-Term Safety And Functional Status Of Subjects With Rheumatoid Arthritis Previously Enrolled In Studies Of CP-690,550
ClinicalTrials.gov ID: NCT00414661
Acronym / sponsor ID: A3921029
Conditions: Arthritis, Rheumatoid
Keywords: Observational non-interventional long-term safety
Study type: Observational
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 21 Dec 2006 (estimated)
Results: Posted 1 Jan 2013

Clinical summary

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

Detailed description

At their last visit of a qualifying study, eligible subjects will be given the opportunity to participate in this study.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Study group	–	Drug: CP-690,550All enrolled subjects

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects who have received at least one dose of study drug and ceased participation in any Phase 2B or 3 randomized, controlled or open-label (qualifying) study of CP-690,550 for the treatment of RA, but are no longer receiving CP-690,550.

Key inclusion criteria (1 listed)

Subjects who have completed all participation in any other Phase 2B or Phase 3 studies of CP-690,550 for rheumatoid arthritis.

Key exclusion criteria (1 listed)

Any subject who refuses consent.

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-690,550Subjects had to have received CP-690,550 or other blinded study drug in index study. No intervention in this long-term follow-up trial.	Drug	Study group

Primary outcome

Incidence of Lymphoproliferative Disorders (LPD)
Time frame: Up to Month 24
Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with LPD by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.
Incidence of Lymphoma
Time frame: Up to Month 24
Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with lymphoma by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.
Incidence of Important Infections
Time frame: Up to Month 24
Incidence rate was calculated separately for active treatment period and follow-up period in previous studies as number of participants with important infections by number of days while on active treatment or during follow-up period per 100 person-years. Standardization of incidence rates was based upon the age and sex distribution of the entire study population.

Results and safety

Results posted to the registry on 1 Jan 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
CP-690,550 >=10 mg	48	34
CP-690,550 <10 mg	89	75
Placebo	22	20
Adalimumab	3	0

Primary outcome: Incidence of Lymphoproliferative Disorders (LPD)

Time frame: Up to Month 24. Number (95% Confidence Interval). Unit: LPD per 100 person-years

Measure	CP-690,550 >=10 mg n = 48	CP-690,550 <10 mg n = 89	Placebo n = 22	Adalimumab n = 3
Value	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Population analysed: Safety analysis set included all participants who were previously enrolled in either randomized, controlled or open-label studies of CP-690,550 and had signed the informed consent form for this study.

Primary outcome: Incidence of Lymphoma

Time frame: Up to Month 24. Number (95% Confidence Interval). Unit: Lymphoma per 100 person-years

Measure	CP-690,550 >=10 mg n = 48	CP-690,550 <10 mg n = 89	Placebo n = 22	Adalimumab n = 3
Value	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)

Primary outcome: Incidence of Important Infections

Time frame: Up to Month 24. Number (95% Confidence Interval). Unit: Infections per 100 person-years

Measure	CP-690,550 >=10 mg n = 48	CP-690,550 <10 mg n = 89	Placebo n = 22	Adalimumab n = 3
Value	0.000 (0.000 to NA)	0.607 (0.086 to 4.312)	0.000 (0.000 to NA)	0.000 (0.000 to NA)

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CP-690,550 >=10 mg	0 of 48 (0%)	3 of 48 (6.3%)	Not reported
CP-690,550 <10 mg	1 of 89 (1.1%)	2 of 89 (2.2%)	Not reported
Placebo	0 of 22 (0%)	1 of 22 (4.5%)	Not reported
Adalimumab	0 of 3 (0%)	0 of 3 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Arthritis, Rheumatoid

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis, Rheumatoid, run by Pfizer at 72 sites in 21 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 1 inclusion and 1 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 1 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, South Korea, Czechia, Poland, Brazil and 16 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jan 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?

Incidence of Lymphoproliferative Disorders (LPD) (time frame: Up to Month 24). The study lists 3 primary outcomes in all. 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 NCT00414661.

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 1 Jan 2013.