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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00414661
• Collaborator: (none)
• Enrollment: 162
• Locations: 72
• Duration (Months): 58.1
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid	Drug: CP-690,550

Detailed Description

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

Study Design

• Study Type: Observational
• Actual Enrollment: 162 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Study group All enrolled subjects	Drug: CP-690,550; 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.

Outcome Measures

Primary Outcome Measures

1. Incidence of Lymphoproliferative Disorders (LPD) [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.

2. Incidence of Lymphoma [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.

3. Incidence of Important Infections [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.

Other Outcome Measures

1. Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [Baseline, Month 6, 12, 18, 24]

   HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Any subject who refuses consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Gilbert	Arizona	United States	85234
2	Pfizer Investigational Site	Tucson	Arizona	United States	85704
3	Pfizer Investigational Site	Palo Alto	California	United States	94304
4	Pfizer Investigational Site	San Diego	California	United States	92108
5	Pfizer Investigational Site	Stanford	California	United States	94305
6	Pfizer Investigational Site	Upland	California	United States	91786
7	Pfizer Investigational Site	Ocala	Florida	United States	34474
8	Pfizer Investigational Site	Orlando	Florida	United States	32804
9	Pfizer Investigational Site	Sarasota	Florida	United States	34233
10	Pfizer Investigational Site	Tampa	Florida	United States	33613
11	Pfizer Investigational Site	Tampa	Florida	United States	33614
12	Pfizer Investigational Site	Venice	Florida	United States	34292
13	Pfizer Investigational Site	Rockford	Illinois	United States	61107
14	Pfizer Investigational Site	Lincoln	Nebraska	United States	68516
15	Pfizer Investigational Site	Albany	New York	United States	12206-1043
16	Pfizer Investigational Site	Hickory	North Carolina	United States	28601
17	Pfizer Investigational Site	Hickory	North Carolina	United States	28602
18	Pfizer Investigational Site	Wyomissing	Pennsylvania	United States	19610
19	Pfizer Investigational Site	Mesquite	Texas	United States	75150
20	Pfizer Investigational Site	Tacoma	Washington	United States	98405-2308
21	Pfizer Investigational Site	Tacoma	Washington	United States	98405
22	Pfizer Investigational Site	Buenos Aires		Argentina	C1034ACO
23	Pfizer Investigational Site	Buenos Aires		Argentina	C1114AAH
24	Pfizer Investigational Site	Goiania	GO	Brazil	74110-120
25	Pfizer Investigational Site	Rio de Janeiro	RJ	Brazil	22271-100
26	Pfizer Investigational Site	Sao Paulo	SP	Brazil	01323-903
27	Pfizer Investigational Site	Sao Paulo	SP	Brazil	04266-010
28	Pfizer Investigational Site	Sofia		Bulgaria	1612
29	Pfizer Investigational Site	Victoria	British Columbia	Canada	V8V 3P9
30	Pfizer Investigational Site	Santiago	RM	Chile	7500922
31	Pfizer Investigational Site	Santiago	RM	Chile	7501126
32	Pfizer Investigational Site	Providencia	Santiago, RM	Chile	7500710
33	Pfizer Investigational Site	Brno		Czech Republic	656 91
34	Pfizer Investigational Site	Ceske Budejovice		Czech Republic	370 01
35	Pfizer Investigational Site	Praha 11 - Chodov		Czech Republic	148 00
36	Pfizer Investigational Site	Praha 2		Czech Republic	128 50
37	Pfizer Investigational Site	Praha 4		Czech Republic	140 00
38	Pfizer Investigational Site	Santo Domingo		Dominican Republic	00000
39	Pfizer Investigational Site	Hyvinkaa		Finland	05800
40	Pfizer Investigational Site	Athens	Goudi	Greece	11527
41	Pfizer Investigational Site	Thessaloniki		Greece	54 636
42	Pfizer Investigational Site	Budapest		Hungary	H-1036
43	Pfizer Investigational Site	Szolnok		Hungary	H-5000
44	Pfizer Investigational Site	Veszprem		Hungary	H-8200
45	Pfizer Investigational Site	Ahmedabad	Gujarat	India	380 015
46	Pfizer Investigational Site	Mangalore	Karnataka	India	575 001
47	Pfizer Investigational Site	Pune	Maharashtra	India	411 001
48	Pfizer Investigational Site	Firenze		Italy	50139
49	Pfizer Investigational Site	Genova		Italy	16132
50	Pfizer Investigational Site	Kitakyusyu	Fukuoka	Japan
51	Pfizer Investigational Site	Higashihiroshima	Hiroshima	Japan
52	Pfizer Investigational Site	Sagamihara	Kanagawa	Japan
53	Pfizer Investigational Site	Shinjyuku-ku	Tokyo	Japan
54	Pfizer Investigational Site	Daejeon		Korea, Republic of	302-799
55	Pfizer Investigational Site	Gwangju		Korea, Republic of	501-757
56	Pfizer Investigational Site	Incheon		Korea, Republic of	400-711
57	Pfizer Investigational Site	Seoul		Korea, Republic of	110-744
58	Pfizer Investigational Site	Seoul		Korea, Republic of	120-752
59	Pfizer Investigational Site	Seoul		Korea, Republic of	133-792
60	Pfizer Investigational Site	Mexico	D.f.	Mexico	06726
61	Pfizer Investigational Site	Mexico	DF	Mexico	14000
62	Pfizer Investigational Site	Bialystok		Poland	15-950
63	Pfizer Investigational Site	Poznan		Poland	60-773
64	Pfizer Investigational Site	Sopot		Poland	81-759
65	Pfizer Investigational Site	Warszawa		Poland	02-256
66	Pfizer Investigational Site	Wroclaw		Poland	50-088
67	Pfizer Investigational Site	San Juan		Puerto Rico	00918
68	Pfizer Investigational Site	Bratislava		Slovakia	81109
69	Pfizer Investigational Site	Piestany		Slovakia	921 01
70	Pfizer Investigational Site	Zilina		Slovakia	012 07
71	Pfizer Investigational Site	Guadalajara		Spain	19002
72	Pfizer Investigational Site	Vinnitsa		Ukraine	21018

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00414661
• Other Study ID Numbers: A3921029
• First Posted: Dec 21, 2006
• Last Update Posted: Jan 1, 2013
• Last Verified: Nov 1, 2012

• Keywords provided by Pfizer: Observational non-interventional long-term safety
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Tofacitinib

Study Results

Participant Flow

Recruitment Details	Participants who received at least 1 dose of CP-690,550, placebo or adalimumab for the treatment of Rheumatoid Arthritis (RA) in previous studies and had ceased participation in other Phase 2B or 3 randomized, controlled or open-label study of CP-690,550 were eligible for this study.

Arm/Group Title	CP-690,550 >=10 mg	CP-690,550 <10 mg	Placebo	Adalimumab
Arm/Group Description	Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.	Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.	Participants who had received 1 dose of matching-placebo in any of the previous studies.	Participants who had received 1 dose of adalimumab in any of the previous studies.
Period Title: Overall Study
STARTED	48	89	22	3
COMPLETED	34	75	20	0
NOT COMPLETED	14	14	2	3

Baseline Characteristics

Arm/Group Title	CP-690,550 >=10 mg	CP-690,550 <10 mg	Placebo	Adalimumab	Total
Arm/Group Description	Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.	Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.	Participants who had received 1 dose of matching-placebo in any of the previous studies.	Participants who had received 1 dose of adalimumab in any of the previous studies.	Total of all reporting groups
Overall Participants	48	89	22	3	162
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.2 (10.8)	54.7 (11.6)	51.8 (13.5)	52.3 (16.0)	55.0 (11.7)
Sex: Female, Male (Count of Participants)
Female	40 83.3%	72 80.9%	17 77.3%	3 100%	132 81.5%
Male	8 16.7%	17 19.1%	5 22.7%	0 0%	30 18.5%

Outcome Measures

1. Primary Outcome

Title	Incidence of Lymphoproliferative Disorders (LPD)
Description	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.
Time Frame	Up to Month 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CP-690,550 >=10 mg	CP-690,550 <10 mg	Placebo	Adalimumab
Arm/Group Description	Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.	Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.	Participants who had received 1 dose of matching-placebo in any of the previous studies.	Participants who had received 1 dose of adalimumab in any of the previous studies.
Measure Participants	48	89	22	3
Number (95% Confidence Interval) [LPD per 100 person-years]	NA	NA	NA	NA

2. Primary Outcome

Title	Incidence of Lymphoma
Description	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.
Time Frame	Up to Month 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CP-690,550 >=10 mg	CP-690,550 <10 mg	Placebo	Adalimumab
Arm/Group Description	Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.	Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.	Participants who had received 1 dose of matching-placebo in any of the previous studies.	Participants who had received 1 dose of adalimumab in any of the previous studies.
Measure Participants	48	89	22	3
Number (95% Confidence Interval) [Lymphoma per 100 person-years]	NA	NA	NA	NA

3. Primary Outcome

Title	Incidence of Important Infections
Description	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.
Time Frame	Up to Month 24

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	CP-690,550 >=10 mg	CP-690,550 <10 mg	Placebo	Adalimumab
Arm/Group Description	Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.	Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.	Participants who had received 1 dose of matching-placebo in any of the previous studies.	Participants who had received 1 dose of adalimumab in any of the previous studies.
Measure Participants	48	89	22	3
Number (95% Confidence Interval) [Infections per 100 person-years]	0.000	0.607	0.000	0.000

4. Other Pre-specified Outcome

Title	Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Description	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame	Baseline, Month 6, 12, 18, 24

Outcome Measure Data

Analysis Population Description

Safety analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for the measure and 'n' signifies participants evaluable at each time point for each arm respectively.

Arm/Group Title	CP-690,550 >=10 mg	CP-690,550 <10 mg	Placebo	Adalimumab
Arm/Group Description	Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.	Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.	Participants who had received 1 dose of matching-placebo in any of the previous studies.	Participants who had received 1 dose of adalimumab in any of the previous studies.
Measure Participants	48	88	22	3
Baseline (n= 48, 88, 22, 3)	1.32 (0.67)	1.42 (0.67)	1.63 (0.76)	1.13 (0.13)
Month 6 (n= 37, 81, 21, 2)	1.08 (0.61)	1.23 (0.69)	1.21 (0.82)	0.19 (0.27)
Month 12 (n= 39, 79, 21, 1)	1.16 (0.63)	1.12 (0.76)	1.15 (0.81)	0.88 (NA)
Month 18 (n= 35, 76, 20, 0)	1.15 (0.59)	1.07 (0.77)	1.12 (0.86)	NA (NA)
Month 24 (n= 31, 68, 20, 0)	1.15 (0.69)	1.14 (0.78)	1.07 (0.87)	NA (NA)

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	CP-690,550 >=10 mg		CP-690,550 <10 mg		Placebo		Adalimumab
Arm/Group Description	Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.		Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.		Participants who had received 1 dose of matching-placebo in any of the previous studies.		Participants who had received 1 dose of adalimumab in any of the previous studies.
All Cause Mortality
	CP-690,550 >=10 mg		CP-690,550 <10 mg		Placebo		Adalimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	CP-690,550 >=10 mg		CP-690,550 <10 mg		Placebo		Adalimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		1/89 (1.1%)		0/22 (0%)		0/3 (0%)
Infections and infestations
Tuberculosis	0/48 (0%)		1/89 (1.1%)		0/22 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	CP-690,550 >=10 mg		CP-690,550 <10 mg		Placebo		Adalimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/48 (6.3%)		2/89 (2.2%)		1/22 (4.5%)		0/3 (0%)
Infections and infestations
Herpes zoster	2/48 (4.2%)		0/89 (0%)		0/22 (0%)		0/3 (0%)
Pneumonia	1/48 (2.1%)		0/89 (0%)		0/22 (0%)		0/3 (0%)
Tooth abscess	0/48 (0%)		0/89 (0%)		1/22 (4.5%)		0/3 (0%)
Urinary tract infection	1/48 (2.1%)		2/89 (2.2%)		1/22 (4.5%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.