Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00413699
First received: December 18, 2006
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550

A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: CP-690,550
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-Term, Open-Label Follow-Up Study Of Tofacitinib (CP-690,550) For Treatment Of Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Primary endpoints will be standard laboratory safety data (chemistry, hematology, etc.) and adverse event (AE) reports [ Time Frame: Every visit until last observation ] [ Designated as safety issue: Yes ]
  • The long-term safety and tolerability of CP-690,550 5 mg BID and 10 mg BID for the treatment of rheumatoid arthritis [ Time Frame: Every visit until last observation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent of patients with ACR 20, 50, and 70 responses [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
  • Area under ACR n curve [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
  • DAS 28 (CRP) and DAS 28 (ESR)as well as incidence of Disease Activity Score <2.6 and <3.2 [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
  • HAQ DI score [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
  • SF 36 score [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
  • FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire [ Time Frame: Every visit until last observation. ] [ Designated as safety issue: No ]
  • Preservation of joint structure in patients who had baseline radiographs obtained in their qualifying index study [ Time Frame: Every 6 months until last observation. ] [ Designated as safety issue: No ]
  • Vaccine sub-study endpoints: 1. % achieving a satisfactory humoral response to the pneumococcal vaccine as defined by ≥ 2-fold increase in antibody concentrations [ Time Frame: at vaccine substudy visit 2 and 4 ] [ Designated as safety issue: No ]
  • Vaccine sub-study 2. % achieving a satisfactory humoral response to the seasonal influenza vaccine as defined by ≥ 4-fold increase in antibody titers [ Time Frame: at vaccine substudy visit 2 and 4 ] [ Designated as safety issue: No ]
  • 1. Percentage of subjects achieving protective antibody titers to the seasonal influenza vaccine as measured by a hemagglutination inhibition (HI) assay titer of ≥ 1:40 in ≥ 2 of 3 influenza antigens measured at vaccine sub-study [ Time Frame: at visit 2 and 4 ] [ Designated as safety issue: No ]
  • 2. Percentage of subjects who respond to each of the 12 pneumococcal antigens as defined by ≥ 2-fold increase in antibody concentrations from vaccine sub-study visit 2 (vaccination baseline) measured at vaccine sub-study visit 4 [ Time Frame: at visit 2 and 4 ] [ Designated as safety issue: No ]
  • 3. Percentage of subjects who respond to each of the 3 influenza antigens as defined by ≥ 4-fold increase in antibody titers from vaccine sub-study visit 2 (vaccination baseline) measured at vaccine sub-study visit 4 [ Time Frame: at visit 2 and 4 ] [ Designated as safety issue: No ]
  • 4. Fold increase of anti-pneumococcal antibody levels to each of the 12 pneumococcal antigens above vaccination baseline values (vaccine sub-study visit 2) at vaccine sub-study visit 4 [ Time Frame: at visit 2 and 4 ] [ Designated as safety issue: No ]
  • 5. Fold increase of anti-influenza antibody levels to each of the 3 influenza antigens above vaccination baseline values (vaccine sub-study visit 2) at vaccine sub-study visit 4 [ Time Frame: at visit 2 and 4 ] [ Designated as safety issue: No ]
  • 6. Concentrations of anti-pneumococcal antibodies at vaccine sub-study visit 3 and 4 [ Time Frame: at visit 3 and 4 ] [ Designated as safety issue: No ]
  • 7. Titers of anti-influenza antibodies at vaccine sub-study visit 3 and 4 [ Time Frame: at visit 3 and 4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 4385
Study Start Date: February 2007
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-Label Active Treatment Enrolled from Phase 2
Patients enrolling from Phase 2 studies
Drug: CP-690,550
5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.
Experimental: Open-Label Active Treatment Enrolled from Phase 3
Patients enrolling from Phase 3 studies
Drug: CP-690,550
10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have participated in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis

Vaccine sub-study visit

  • Subjects actively participating in Study A3921024 must have completed at least 3 months of continuous 10 mg BID CP-690,550 treatment in A3921024 as defined by >80% compliance with prescribed dose consumption of CP-690,550 over the previous 3 months.

Exclusion Criteria:

  • Serious medical conditions that would make treatment with CP-690,550 potentially unsafe

Vaccine sub-study visit

  1. Any documented influenza or pneumococcal infection within the last 3 months prior to randomization in this study
  2. Received any vaccine within 1 month prior to randomization in this study
  3. Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of randomization in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413699

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site Recruiting
Birmingham, Alabama, United States, 35294
Pfizer Investigational Site Recruiting
Huntsville, Alabama, United States, 35801
United States, Arizona
Pfizer Investigational Site Recruiting
Gilbert, Arizona, United States, 85234
Pfizer Investigational Site Recruiting
Glendale, Arizona, United States, 85304
Pfizer Investigational Site Recruiting
Paradise Valley, Arizona, United States, 85253
Pfizer Investigational Site Recruiting
Paradise Valley, Arizona, United States, 85202
Pfizer Investigational Site Recruiting
Phoenix, Arizona, United States, 85037
Pfizer Investigational Site Recruiting
Phoenix, Arizona, United States, 85032-9385
Pfizer Investigational Site Recruiting
Scottsdale, Arizona, United States, 85251
Pfizer Investigational Site Completed
Tucson, Arizona, United States, 85704
United States, Arkansas
Pfizer Investigational Site Recruiting
Hot Springs, Arkansas, United States, 71913
Pfizer Investigational Site Recruiting
Jonesboro, Arkansas, United States, 72401
Pfizer Investigational Site Terminated
Little Rock, Arkansas, United States, 72201
Pfizer Investigational Site Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site Recruiting
Fair Oaks, California, United States, 95628
Pfizer Investigational Site Recruiting
Huntington Beach, California, United States, 92646
Pfizer Investigational Site Recruiting
La Jolla, California, United States, 92037
Pfizer Investigational Site Recruiting
La Jolla, California, United States, 92093
Pfizer Investigational Site Recruiting
LaJolla, California, United States, 92037-0943
Pfizer Investigational Site Recruiting
Los Angeles, California, United States, 90095
Pfizer Investigational Site Recruiting
Los Angeles, California, United States, 90033
Pfizer Investigational Site Terminated
Palo Alto, California, United States, 94304
Pfizer Investigational Site Recruiting
Roseville, California, United States, 95661
Pfizer Investigational Site Recruiting
San Diego, California, United States, 92108
Pfizer Investigational Site Recruiting
Santa Maria, California, United States, 93454
Pfizer Investigational Site Terminated
Stanford, California, United States, 94305
Pfizer Investigational Site Recruiting
Upland, California, United States, 91786
United States, Colorado
Pfizer Investigational Site Recruiting
Boulder, Colorado, United States, 80304
Pfizer Investigational Site Terminated
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Pfizer Investigational Site Recruiting
Farmington, Connecticut, United States, 06030-5353
Pfizer Investigational Site Terminated
Hamden, Connecticut, United States, 06518
Pfizer Investigational Site Recruiting
Trumbull, Connecticut, United States, 06611
United States, Delaware
Pfizer Investigational Site Completed
Newark, Delaware, United States, 19713
United States, Florida
Pfizer Investigational Site Recruiting
Aventura, Florida, United States, 33180
Pfizer Investigational Site Recruiting
Daytona Beach, Florida, United States, 32114
Pfizer Investigational Site Terminated
Debary, Florida, United States, 32713
Pfizer Investigational Site Active, not recruiting
Gainesville, Florida, United States, 32607
Pfizer Investigational Site Recruiting
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site Recruiting
Largo, Florida, United States, 33777
Pfizer Investigational Site Recruiting
Miami, Florida, United States, 33143
Pfizer Investigational Site Recruiting
Miami, Florida, United States, 33173
Pfizer Investigational Site Recruiting
Naples, Florida, United States, 34102
Pfizer Investigational Site Recruiting
New Port Richey, Florida, United States, 34652
Pfizer Investigational Site Active, not recruiting
Ocala, Florida, United States, 34474
Pfizer Investigational Site Recruiting
Orlando, Florida, United States, 32804
Pfizer Investigational Site Recruiting
Ormond Beach, Florida, United States, 32174
Pfizer Investigational Site Recruiting
Pinellas Park, Florida, United States, 33782
Pfizer Investigational Site Recruiting
Port Richey, Florida, United States, 34668
Pfizer Investigational Site Recruiting
Sarasota, Florida, United States, 34233
Pfizer Investigational Site Recruiting
Sarasota, Florida, United States, 34239
Pfizer Investigational Site Recruiting
St. Petersburg, Florida, United States, 33710
Pfizer Investigational Site Recruiting
Tamarac, Florida, United States, 33321
Pfizer Investigational Site Recruiting
Tampa, Florida, United States, 33613
Pfizer Investigational Site Recruiting
Tampa, Florida, United States, 33614
Pfizer Investigational Site Recruiting
Venice, Florida, United States, 34292
Pfizer Investigational Site Recruiting
Zephyrhills, Florida, United States, 33542
United States, Georgia
Pfizer Investigational Site Recruiting
Atlanta, Georgia, United States, 30342
Pfizer Investigational Site Recruiting
Decatur, Georgia, United States, 30333
Pfizer Investigational Site Recruiting
Marietta, Georgia, United States, 30060
United States, Idaho
Pfizer Investigational Site Completed
Boise, Idaho, United States, 83702
Pfizer Investigational Site Recruiting
Idaho Falls, Idaho, United States, 83404
Pfizer Investigational Site Completed
Meridian, Idaho, United States, 83642
United States, Illinois
Pfizer Investigational Site Terminated
Maywood, Illinois, United States, 60153
Pfizer Investigational Site Recruiting
Morton Grove, Illinois, United States, 60053
Pfizer Investigational Site Recruiting
Rockford, Illinois, United States, 61114
Pfizer Investigational Site Terminated
Rockford, Illinois, United States, 61103-3692
Pfizer Investigational Site Recruiting
Springfield, Illinois, United States, 62704
Pfizer Investigational Site Recruiting
Vernon Hills, Illinois, United States, 60061
United States, Indiana
Pfizer Investigational Site Recruiting
Indianapolis, Indiana, United States, 46227
United States, Iowa
Pfizer Investigational Site Recruiting
Cedar Rapids, Iowa, United States, 52403
Pfizer Investigational Site Completed
Dubuque, Iowa, United States, 52002
United States, Kansas
Pfizer Investigational Site Completed
Wichita, Kansas, United States, 67208
Pfizer Investigational Site Recruiting
Wichita, Kansas, United States, 67203
United States, Kentucky
Pfizer Investigational Site Recruiting
Lexington, Kentucky, United States, 40504
United States, Louisiana
Pfizer Investigational Site Recruiting
Baton Rouge, Louisiana, United States, 70809
Pfizer Investigational Site Active, not recruiting
New Orleans, Louisiana, United States, 70115
United States, Maine
Pfizer Investigational Site Recruiting
Portland, Maine, United States, 04102
United States, Maryland
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Cumberland, Maryland, United States, 21502
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Frederick, Maryland, United States, 21702
Pfizer Investigational Site Recruiting
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Pfizer Investigational Site Completed
Hyannis, Massachusetts, United States, 02601
Pfizer Investigational Site Recruiting
Leominster, Massachusetts, United States, 01453
Pfizer Investigational Site Recruiting
Lincoln Street, Massachusetts, United States, 01605
Pfizer Investigational Site Completed
West Yarmouth, Massachusetts, United States, 02673
Pfizer Investigational Site Recruiting
Worcester, Massachusetts, United States, 01608
Pfizer Investigational Site Recruiting
Worcester, Massachusetts, United States, 01605
Pfizer Investigational Site Recruiting
Worcester, Massachusetts, United States, 01610
United States, Michigan
Pfizer Investigational Site Recruiting
Battle Creek, Michigan, United States, 49015
Pfizer Investigational Site Recruiting
Bingham Farms, Michigan, United States, 48025
Pfizer Investigational Site Recruiting
Kalamazoo, Michigan, United States, 49009
Pfizer Investigational Site Recruiting
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
Pfizer Investigational Site Recruiting
Edina, Minnesota, United States, 55435
United States, Mississippi
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Tupelo, Mississippi, United States, 38801
United States, Missouri
Pfizer Investigational Site Recruiting
Columbia, Missouri, United States, 65203
Pfizer Investigational Site Recruiting
Columbia, Missouri, United States, 65212
Pfizer Investigational Site Recruiting
Lee's Summit, Missouri, United States, 64086
United States, Nebraska
Pfizer Investigational Site Recruiting
Lincoln, Nebraska, United States, 68516
Pfizer Investigational Site Completed
Omaha, Nebraska, United States, 68134
Pfizer Investigational Site Recruiting
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Pfizer Investigational Site Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Pfizer Investigational Site Active, not recruiting
Teaneck, New Jersey, United States, 07666
Pfizer Investigational Site Terminated
Voorhees, New Jersey, United States, 08043
United States, New York
Pfizer Investigational Site Recruiting
Albany, New York, United States, 12206
Pfizer Investigational Site Recruiting
Binghamton, New York, United States, 13905
Pfizer Investigational Site Recruiting
Olean, New York, United States, 14760
Pfizer Investigational Site Recruiting
Orchard Park, New York, United States, 14127
Pfizer Investigational Site Recruiting
Rochester, New York, United States, 14618
United States, North Carolina
Pfizer Investigational Site Recruiting
Asheville, North Carolina, United States, 28801
Pfizer Investigational Site Recruiting
Asheville, North Carolina, United States, 28803
Pfizer Investigational Site Recruiting
Charlotte, North Carolina, United States, 28210
Pfizer Investigational Site Recruiting
Hickory, North Carolina, United States, 28602
Pfizer Investigational Site Recruiting
Hickory, North Carolina, United States, 28601
Pfizer Investigational Site Active, not recruiting
Rocky Mount, North Carolina, United States, 27804
United States, North Dakota
Pfizer Investigational Site Recruiting
Minot, North Dakota, United States, 58701
United States, Ohio
Pfizer Investigational Site Recruiting
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site Recruiting
Dayton, Ohio, United States, 45417
Pfizer Investigational Site Recruiting
Mayfield Village, Ohio, United States, 44143
United States, Oklahoma
Pfizer Investigational Site Recruiting
Oklahoma City, Oklahoma, United States, 73104
Pfizer Investigational Site Recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Pfizer Investigational Site Recruiting
Bethlehem, Pennsylvania, United States, 18015
Pfizer Investigational Site Recruiting
Duncansville, Pennsylvania, United States, 16635
Pfizer Investigational Site Active, not recruiting
West Reading, Pennsylvania, United States, 19611
Pfizer Investigational Site Recruiting
Willow Grove, Pennsylvania, United States, 19090
Pfizer Investigational Site Active, not recruiting
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Pfizer Investigational Site Recruiting
Greenville, South Carolina, United States, 29601
Pfizer Investigational Site Recruiting
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Pfizer Investigational Site Recruiting
Hixson, Tennessee, United States, 37343
Pfizer Investigational Site Recruiting
Jackson, Tennessee, United States, 38305
Pfizer Investigational Site Recruiting
Knoxville, Tennessee, United States, 37909-1907
Pfizer Investigational Site Completed
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site Recruiting
Allen, Texas, United States, 75013
Pfizer Investigational Site Recruiting
Austin, Texas, United States, 78705
Pfizer Investigational Site Recruiting
Dallas, Texas, United States, 75231
Pfizer Investigational Site Recruiting
Dallas, Texas, United States, 75231-4496
Pfizer Investigational Site Recruiting
Dallas, Texas, United States, 75235
Pfizer Investigational Site Terminated
Fort Worth, Texas, United States, 76107
Pfizer Investigational Site Recruiting
Houston, Texas, United States, 77074
Pfizer Investigational Site Recruiting
Houston, Texas, United States, 77034
Pfizer Investigational Site Recruiting
Lubbock, Texas, United States, 79424
Pfizer Investigational Site Recruiting
Mesquite, Texas, United States, 75150
United States, Washington
Pfizer Investigational Site Recruiting
Seattle, Washington, United States, 98133
Pfizer Investigational Site Recruiting
Seattle, Washington, United States, 98122
Pfizer Investigational Site Terminated
Seattle, Washington, United States, 98101
Pfizer Investigational Site Completed
Tacoma, Washington, United States, 98405
Pfizer Investigational Site Recruiting
Vancouver, Washington, United States, 98664
United States, West Virginia
Pfizer Investigational Site Recruiting
Clarksburg, West Virginia, United States, 26301
United States, Wisconsin
Pfizer Investigational Site Recruiting
Onalaska, Wisconsin, United States, 54650
Pfizer Investigational Site Recruiting
Onalaska, Wisconsin, United States, 54601
Argentina
Pfizer Investigational Site Recruiting
Buenos Aires, Argentina, C1015ABO
Pfizer Investigational Site Recruiting
Buenos Aires, Argentina, C1114AAH
Pfizer Investigational Site Recruiting
Buenos Aires, Argentina, C1419AHN
Pfizer Investigational Site Terminated
Buenos Aires, Argentina, C1034ACO
Pfizer Investigational Site Completed
Buenos Aires, Argentina, C1428DZF
Pfizer Investigational Site Recruiting
Buenos Aires, Argentina, C1426ABP
Australia, New South Wales
Pfizer Investigational Site Recruiting
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Pfizer Investigational Site Terminated
Cairns, Queensland, Australia, 4870
Pfizer Investigational Site Recruiting
Maroochydore, Queensland, Australia, 4558
Australia, South Australia
Pfizer Investigational Site Recruiting
Woodville, South Australia, Australia, 5011
Australia, Victoria
Pfizer Investigational Site Recruiting
Malvern East, Victoria, Australia, 3145
Australia, Western Australia
Pfizer Investigational Site Recruiting
Shenton Park, Western Australia, Australia, 6008
Australia
Pfizer Investigational Site Recruiting
Kogarah, Australia
Pfizer Investigational Site Recruiting
St. Leonards, Australia, NSW 2065
Austria
Pfizer Investigational Site Active, not recruiting
Wien, Austria, A-1100
Pfizer Investigational Site Completed
Wien, Austria, A-1100
Pfizer Investigational Site Completed
Wien, Austria, 1100
Pfizer Investigational Site Completed
Wien, Austria, A-1090
Belgium
Pfizer Investigational Site Recruiting
Gent, Belgium, 9000
Pfizer Investigational Site Terminated
Kortrijk, Belgium, 8500
Pfizer Investigational Site Recruiting
Liege, Belgium, 4020
Bosnia and Herzegovina
Pfizer Investigational Site Recruiting
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Pfizer Investigational Site Active, not recruiting
Goiania, GO, Brazil, 74110-120
Pfizer Investigational Site Active, not recruiting
Goiânia, GO, Brazil, 74110-120
Pfizer Investigational Site Recruiting
Curitiba, Paraná, Brazil, 80030-110
Pfizer Investigational Site Recruiting
Rio de Janeiro, RJ, Brazil, 22271-100
Pfizer Investigational Site Recruiting
Porto Alegre, RS, Brazil, 90035-903
Pfizer Investigational Site Recruiting
Porto Alegre, RS, Brazil, 90610-000
Pfizer Investigational Site Recruiting
Porto Alegre, RS, Brazil, 90035 903
Pfizer Investigational Site Recruiting
Sao Paulo, SP, Brazil, 05437-010
Pfizer Investigational Site Recruiting
Sao Paulo, SP, Brazil, 04266-010
Pfizer Investigational Site Terminated
Sao Paulo, SP, Brazil, 01323-903
Pfizer Investigational Site Recruiting
Sao Paulo, SP, Brazil, 05403-010
Bulgaria
Pfizer Investigational Site Recruiting
Pleven, Bulgaria, 5800
Pfizer Investigational Site Recruiting
Plovdiv, Bulgaria, 4000
Pfizer Investigational Site Recruiting
Plovdiv, Bulgaria, 4002
Pfizer Investigational Site Recruiting
Sevlievo, Bulgaria, 5400
Pfizer Investigational Site Recruiting
Sofia, Bulgaria, 1612
Pfizer Investigational Site Recruiting
Sofia, Bulgaria, 1606
Pfizer Investigational Site Recruiting
Sofia, Bulgaria, 1709
Pfizer Investigational Site Recruiting
Sofia 1606, Bulgaria
Pfizer Investigational Site Recruiting
Veliko Tarnovo, Bulgaria, 5000
Canada, Alberta
Pfizer Investigational Site Recruiting
Edmonton, Alberta, Canada, T5M 0H4
Canada, British Columbia
Pfizer Investigational Site Active, not recruiting
Vancouver, British Columbia, Canada, V5Z 1L7
Pfizer Investigational Site Recruiting
Victoria, British Columbia, Canada, V8V 3P9
Canada, Manitoba
Pfizer Investigational Site Recruiting
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Newfoundland and Labrador
Pfizer Investigational Site Recruiting
St. John's, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Ontario
Pfizer Investigational Site Active, not recruiting
Burlington, Ontario, Canada, L7L 0B7
Pfizer Investigational Site Recruiting
Hamilton, Ontario, Canada, L8N 1Y2
Pfizer Investigational Site Recruiting
Hamilton, Ontario, Canada, L8N 2B6
Pfizer Investigational Site Recruiting
Kitchener, Ontario, Canada, N2M 5N6
Pfizer Investigational Site Completed
London, Ontario, Canada, N6A 4V2
Pfizer Investigational Site Terminated
Mississauga, Ontario, Canada, L5M 2V8
Pfizer Investigational Site Recruiting
Newmarket, Ontario, Canada, L3Y 3R7
Pfizer Investigational Site Recruiting
Ottawa, Ontario, Canada, K1H 1A2
Pfizer Investigational Site Recruiting
St. Catharines, Ontario, Canada, L2N 7E4
Pfizer Investigational Site Recruiting
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
Pfizer Investigational Site Recruiting
Montreal, Quebec, Canada, H2L 1S6
Pfizer Investigational Site Active, not recruiting
Pointe-Claire, Quebec, Canada, H9R 3J1
Pfizer Investigational Site Completed
Sainte-Foy, Quebec, Canada, G1V 3M7
Pfizer Investigational Site Recruiting
Trois-Rivieres, Quebec, Canada, G8Z 1Y2
Canada, Saskatchewan
Pfizer Investigational Site Recruiting
Saskatoon, Saskatchewan, Canada, S7H-2Z1
Canada
Pfizer Investigational Site Recruiting
Quebec, Canada, G1W 4R4
Chile
Pfizer Investigational Site Active, not recruiting
Temuco, IX Region, Chile, 4790928
Pfizer Investigational Site Recruiting
Valdivia, Region XIV, Chile, 5090145
Pfizer Investigational Site Active, not recruiting
Santiago, RM, Chile, 8360156
Pfizer Investigational Site Active, not recruiting
Santiago, RM, Chile, 7501126
Pfizer Investigational Site Active, not recruiting
Santiago, RM, Chile, 7510186
Pfizer Investigational Site Terminated
Providencia, Santiago, RM, Chile, 7530206
Pfizer Investigational Site Active, not recruiting
Vina del Mar, V Region, Chile, 2570017
Pfizer Investigational Site Completed
Rancagua, Chile, 2841959
Pfizer Investigational Site Active, not recruiting
Santiago, Chile
China, Guangdong
Pfizer Investigational Site Recruiting
Guangzhou, Guangdong, China, 510260
China, Hubei
Pfizer Investigational Site Recruiting
Wuhan, Hubei, China, 430030
China, Hunan
Pfizer Investigational Site Recruiting
Changsha, Hunan, China, 410008
China, Shandong
Pfizer Investigational Site Recruiting
Jinan, Shandong, China, 250012
Pfizer Investigational Site Recruiting
Qingdao, Shandong, China, 266011
China, Shanghai
Pfizer Investigational Site Recruiting
Shanghai, Shanghai, China, 200433
China, Shanxi
Pfizer Investigational Site Recruiting
Xi'an, Shanxi, China, 710032
China, Zhejiang
Pfizer Investigational Site Recruiting
Hangzhou, Zhejiang, China, 310009
China
Pfizer Investigational Site Recruiting
Beijing, China, 100020
Pfizer Investigational Site Recruiting
Beijing, China, 100853
Pfizer Investigational Site Recruiting
Beijing, China, 100044
Pfizer Investigational Site Active, not recruiting
Chengdu, China, 610041
Pfizer Investigational Site Recruiting
Guangzhou, China, 510630
Pfizer Investigational Site Recruiting
Hefei, China, 230001
Pfizer Investigational Site Recruiting
Hefei, China, 230022
Pfizer Investigational Site Recruiting
Nanjing, China, 210029
Pfizer Investigational Site Recruiting
Shanghai, China, 200003
Pfizer Investigational Site Recruiting
Shanghai, China, 200001
Pfizer Investigational Site Recruiting
Suzhou, China, 215006
Pfizer Investigational Site Recruiting
Tianjin, China, 300052
Colombia
Pfizer Investigational Site Recruiting
Barranquilla, Atlantico, Colombia, 0000
Pfizer Investigational Site Recruiting
Bogota, Cundinamarca, Colombia, 0000
Pfizer Investigational Site Recruiting
Bucaramanga, Santander, Colombia, 0000
Pfizer Investigational Site Recruiting
Bogota, Colombia, 0000
Costa Rica
Pfizer Investigational Site Recruiting
Cartago, Costa Rica, 00000
Pfizer Investigational Site Terminated
San Jose, Costa Rica
Croatia
Pfizer Investigational Site Recruiting
Osijek, Croatia, 31000
Pfizer Investigational Site Recruiting
Split, Croatia, 21000
Pfizer Investigational Site Completed
Zagreb, Croatia, 10000
Pfizer Investigational Site Recruiting
Zagreb, Croatia, 10000
Czech Republic
Pfizer Investigational Site Active, not recruiting
Brno, Czech Republic, 625 00
Pfizer Investigational Site Active, not recruiting
Brno, Czech Republic, 61300
Pfizer Investigational Site Active, not recruiting
Brno, Czech Republic, 656 91
Pfizer Investigational Site Active, not recruiting
Brno - Zidenice, Czech Republic, 615 00
Pfizer Investigational Site Recruiting
Ceska Lipa, Czech Republic, 470 01
Pfizer Investigational Site Recruiting
Ceske Budejovice, Czech Republic, 370 01
Pfizer Investigational Site Recruiting
Hlucin, Czech Republic, 748 01
Pfizer Investigational Site Active, not recruiting
Hostivice, Czech Republic, 253 01
Pfizer Investigational Site Recruiting
Hradec Kralove, Czech Republic, 50005
Pfizer Investigational Site Recruiting
Ostrava - Poruba, Czech Republic, 70800
Pfizer Investigational Site Completed
Pardubice, Czech Republic, 530 02
Pfizer Investigational Site Active, not recruiting
Praha 1, Czech Republic, 11000
Pfizer Investigational Site Active, not recruiting
Praha 11 - Chodov, Czech Republic, 148 00
Pfizer Investigational Site Recruiting
Praha 2, Czech Republic, 128 50
Pfizer Investigational Site Recruiting
Praha 2, Czech Republic, 12850
Pfizer Investigational Site Active, not recruiting
Praha 4, Czech Republic, 14000
Pfizer Investigational Site Active, not recruiting
Praha 4, Czech Republic, 140 59
Pfizer Investigational Site Recruiting
Praha 4, Czech Republic, 140 00
Pfizer Investigational Site Recruiting
Praha 4, Czech Republic, 14000
Pfizer Investigational Site Active, not recruiting
Zlin, Czech Republic, 760 01
Denmark
Pfizer Investigational Site Recruiting
Frederiksberg, Denmark, 2000
Dominican Republic
Pfizer Investigational Site Recruiting
Santo Domingo, Dominican Republic, 00000
Finland
Pfizer Investigational Site Recruiting
Helsinki, Finland, 00120
Pfizer Investigational Site Recruiting
Hyvinkaa, Finland, 05800
Pfizer Investigational Site Terminated
Tampere, Finland, 33520
France
Pfizer Investigational Site Terminated
Amiens, France, 80054
Pfizer Investigational Site Completed
Orleans, France, 45000
Pfizer Investigational Site Completed
Paris, France, 75014
Pfizer Investigational Site Completed
Paris, France, 75012
Germany
Pfizer Investigational Site Recruiting
Aachen, Germany, 52064
Pfizer Investigational Site Completed
Berlin, Germany, 10117
Pfizer Investigational Site Recruiting
Berlin, Germany, 14163
Pfizer Investigational Site Recruiting
Berlin, Germany, 14059
Pfizer Investigational Site Completed
Dresden, Germany, 01067
Pfizer Investigational Site Recruiting
Erlangen, Germany, 91054
Pfizer Investigational Site Completed
Frankfurt am Main, Germany, 60590
Pfizer Investigational Site Recruiting
Halle, Germany, 06108
Pfizer Investigational Site Recruiting
Hamburg, Germany, 22081
Pfizer Investigational Site Recruiting
Herne, Germany, 44652
Pfizer Investigational Site Recruiting
Koeln, Germany, 50937
Pfizer Investigational Site Recruiting
Leipzig, Germany, 04103
Pfizer Investigational Site Completed
Muenchen, Germany, 80336
Pfizer Investigational Site Recruiting
Nuernberg, Germany, 90429
Pfizer Investigational Site Recruiting
Ratingen, Germany, 40882
Pfizer Investigational Site Recruiting
Rheine, Germany, 48431
Pfizer Investigational Site Recruiting
Wuerzburg, Germany, 97080
Greece
Pfizer Investigational Site Recruiting
Thessaloniki, Greece, 56429
Pfizer Investigational Site Active, not recruiting
Thessaloniki, Greece, 54 636
Pfizer Investigational Site Active, not recruiting
Thessaloniki, Greece, 54636
Hungary
Pfizer Investigational Site Recruiting
Balatonfured, Hungary, 8230
Pfizer Investigational Site Completed
Budapest, Hungary, 1027
Pfizer Investigational Site Recruiting
Budapest, Hungary, H1036
Pfizer Investigational Site Recruiting
Budapest, Hungary, 1023
Pfizer Investigational Site Recruiting
Szolnok, Hungary, 5000
India
Pfizer Investigational Site Recruiting
Hyderabad, Andhra Pradesh, India, 500 004
Pfizer Investigational Site Active, not recruiting
Secunderabad, Andhra Pradesh, India, 500 003
Pfizer Investigational Site Recruiting
Ahmedabad, Gujarat, India, 380 015
Pfizer Investigational Site Recruiting
Ahmedabad, Gujarat, India, 380054
Pfizer Investigational Site Recruiting
Ahmedabad, Gujarat, India, 380009
Pfizer Investigational Site Active, not recruiting
Bangalore, Karnataka, India, 560 054
Pfizer Investigational Site Active, not recruiting
Bangalore, Karnataka, India, 560 034
Pfizer Investigational Site Terminated
Bangalore, Karnataka, India, 560003
Pfizer Investigational Site Terminated
Bangalore, Karnataka, India, 560 079
Pfizer Investigational Site Recruiting
Pune, Maharashtra, India, 411 001
Pfizer Investigational Site Active, not recruiting
Pune, Maharashtra, India, 411 001
Ireland
Pfizer Investigational Site Recruiting
Dublin, Ireland
Italy
Pfizer Investigational Site Recruiting
Firenze, Italy, 50139
Pfizer Investigational Site Terminated
Genova, Italy, 16132
Korea, Republic of
Pfizer Investigational Site Recruiting
Seoul, Republic Of Korea, Korea, Republic of, 133-792
Pfizer Investigational Site Recruiting
Busan, Korea, Republic of, 602-715
Pfizer Investigational Site Active, not recruiting
Daegu, Korea, Republic of, 705-718
Pfizer Investigational Site Recruiting
Daejeon, Korea, Republic of, 302-799
Pfizer Investigational Site Recruiting
Gwangju, Korea, Republic of, 501-757
Pfizer Investigational Site Recruiting
Incheon, Korea, Republic of, 400-711
Pfizer Investigational Site Recruiting
Seoul, Korea, Republic of, 442-723
Pfizer Investigational Site Recruiting
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site Recruiting
Seoul, Korea, Republic of, 135-720
Pfizer Investigational Site Recruiting
Seoul, Korea, Republic of, 137-701
Pfizer Investigational Site Recruiting
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site Recruiting
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site Recruiting
Seoul, Korea, Republic of, 143-729
Malaysia
Pfizer Investigational Site Recruiting
Kota Kinabalu, Sabah, Malaysia, 88586
Pfizer Investigational Site Recruiting
Petaling Jaya, Selangor Darul Ehsan, Malaysia, 46150
Pfizer Investigational Site Recruiting
Putrajaya, Wilayah Persekutan, Malaysia, 62250
Pfizer Investigational Site Recruiting
Batu Caves, Malaysia, 68100
Pfizer Investigational Site Recruiting
Kuching, Malaysia, 93586
Pfizer Investigational Site Recruiting
Selangor, Malaysia, 47500
Pfizer Investigational Site Recruiting
Seremban, Malaysia, 70300
Mexico
Pfizer Investigational Site Recruiting
Tijuana, Baja California, Mexico, 22010
Pfizer Investigational Site Recruiting
Torreon, Coahuila, Mexico, 27000
Pfizer Investigational Site Recruiting
Mexico, D.f., Mexico, 11850
Pfizer Investigational Site Recruiting
Mexico, DF, Mexico, 14000
Pfizer Investigational Site Recruiting
Metepec, Estado de Mexico, Mexico, 52140
Pfizer Investigational Site Recruiting
Guadalajara, Jalisco, Mexico, 44620
Pfizer Investigational Site Recruiting
Coyoacan, Mexico D.F., Mexico, 04030
Pfizer Investigational Site Recruiting
Morelia, Michoacan, Mexico, 58070
Pfizer Investigational Site Recruiting
Cuernavaca, Morelos, Mexico, 62270
Pfizer Investigational Site Recruiting
Monterrey, Nuevo Leon, Mexico, 64020
Pfizer Investigational Site Recruiting
Merida, Yucatan, Mexico, 97000
Pfizer Investigational Site Recruiting
Chihuahua, Mexico, 31000
Pfizer Investigational Site Recruiting
Guadalajara, Mexico, 44160
Pfizer Investigational Site Recruiting
Mexico, Mexico, 10700
Pfizer Investigational Site Recruiting
Mexico City, Mexico, 11850
Pfizer Investigational Site Recruiting
Morelia, Mexico, 58249
Pfizer Investigational Site Recruiting
Morelos, Mexico, 62170
Pfizer Investigational Site Recruiting
Queretaro, Mexico, 76178
Pfizer Investigational Site Recruiting
San Luis Potosi, Mexico, 78200
Pfizer Investigational Site Recruiting
San Luis Potosi, Mexico, 78240
New Zealand
Pfizer Investigational Site Recruiting
Christchurch, New Zealand, 8022
Pfizer Investigational Site Recruiting
Hamilton, New Zealand, 3204
Pfizer Investigational Site Recruiting
Timaru, New Zealand, 7910
Peru
Pfizer Investigational Site Recruiting
Callao, Peru, C-02
Pfizer Investigational Site Recruiting
Lima, Peru, L-27
Philippines
Pfizer Investigational Site Recruiting
Lipa City, Batangas, Philippines, 4217
Pfizer Investigational Site Terminated
Dasmarinas, Cavite, Philippines, 4114
Pfizer Investigational Site Recruiting
Angeles, Pampanga, Philippines, 2009
Pfizer Investigational Site Recruiting
Manila, Phillipines, Philippines, 1008
Pfizer Investigational Site Recruiting
Cebu City, Philippines, 6000
Pfizer Investigational Site Recruiting
Davao, Philippines, 8000
Pfizer Investigational Site Recruiting
Davao City, Philippines, 8000
Pfizer Investigational Site Terminated
Las Piñas City, Philippines, 1742
Pfizer Investigational Site Recruiting
Madapo, Philippines
Pfizer Investigational Site Recruiting
Manila, Philippines, 1008
Pfizer Investigational Site Not yet recruiting
Manila, Philippines, 1003
Poland
Pfizer Investigational Site Recruiting
Bialystok, Poland, 15-354
Pfizer Investigational Site Recruiting
Bialystok, Poland, 15- 879
Pfizer Investigational Site Recruiting
Cieszyn, Poland, 43-400
Pfizer Investigational Site Recruiting
Koscian, Poland, 64-000
Pfizer Investigational Site Recruiting
Krakow, Poland, 31-501
Pfizer Investigational Site Recruiting
Poznan, Poland, 60-773
Pfizer Investigational Site Recruiting
Sopot, Poland, 81-759
Pfizer Investigational Site Recruiting
Torun, Poland, 87-100
Pfizer Investigational Site Recruiting
Warszawa, Poland, 02-256
Pfizer Investigational Site Recruiting
Warszawa, Poland, 02-118
Pfizer Investigational Site Recruiting
Warszawa, Poland, 01-192
Pfizer Investigational Site Recruiting
Wroclaw, Poland, 50-088
Puerto Rico
Pfizer Investigational Site Recruiting
Ponce, Puerto Rico, 00717
Pfizer Investigational Site Recruiting
Ponce, Puerto Rico, 00716
Pfizer Investigational Site Recruiting
San Juan, Puerto Rico, 00918
Romania
Pfizer Investigational Site Recruiting
Bucuresti, Romania, 011172
Pfizer Investigational Site Recruiting
Iasi, Romania, 700661
Russian Federation
Pfizer Investigational Site Recruiting
Novosibirsk, Novosibirsk Region, Russian Federation, 630091
Pfizer Investigational Site Recruiting
Barnaul, Russian Federation, 656024
Pfizer Investigational Site Recruiting
Ekaterinburg, Russian Federation, 620149
Pfizer Investigational Site Recruiting
Ekaterinburg, Russian Federation, 620102
Pfizer Investigational Site Recruiting
Kemerovo, Russian Federation, 650099
Pfizer Investigational Site Completed
Moscow, Russian Federation, 115093
Pfizer Investigational Site Recruiting
Moscow, Russian Federation, 115522
Pfizer Investigational Site Recruiting
Petrozavodsk, Russian Federation, 185019
Pfizer Investigational Site Recruiting
Saint-Petersburg, Russian Federation, 197341
Pfizer Investigational Site Recruiting
Smolensk, Russian Federation, 214019
Pfizer Investigational Site Recruiting
St. Petersburg, Russian Federation, 198260
Pfizer Investigational Site Recruiting
St. Petersburg, Russian Federation, 194291
Pfizer Investigational Site Recruiting
St. Petersburg, Russian Federation, 190068
Pfizer Investigational Site Recruiting
St.Petersburg, Russian Federation, 197706
Pfizer Investigational Site Recruiting
Tomsk, Russian Federation, 634063
Slovakia
Pfizer Investigational Site Recruiting
Bratislava, Slovakia, 82606
Pfizer Investigational Site Completed
Bratislava, Slovakia, 832 99
Pfizer Investigational Site Recruiting
Dunajska Streda, Slovakia, 92901
Pfizer Investigational Site Recruiting
Kosice, Slovakia, 040 01
Pfizer Investigational Site Recruiting
Nove Zamky, Slovakia, 94001
Pfizer Investigational Site Recruiting
Piestany, Slovakia, 921 01
Pfizer Investigational Site Recruiting
Poprad, Slovakia, 058 01
Pfizer Investigational Site Recruiting
Rimavska Sobota, Slovakia, 979 01
Pfizer Investigational Site Recruiting
Senica, Slovakia, 905 01
Pfizer Investigational Site Recruiting
Zilina, Slovakia, 012 07
Spain
Pfizer Investigational Site Recruiting
Santiago de Compostela, A Coruña, Spain, 15706
Pfizer Investigational Site Recruiting
Merida, Badajoz, Spain, 06800
Pfizer Investigational Site Recruiting
Santander, Cantabria, Spain, 39008
Pfizer Investigational Site Terminated
Dos Hermanas, Sevilla, Spain, 41700
Pfizer Investigational Site Recruiting
Barakaldo, Vizcaya, Spain, 48903
Pfizer Investigational Site Recruiting
Bilbao, Vizcaya, Spain, 48013
Pfizer Investigational Site Completed
Barcelona, Spain, 08003
Pfizer Investigational Site Recruiting
La Coruna, Spain, 15006
Pfizer Investigational Site Recruiting
Madrid, Spain, 28046
Pfizer Investigational Site Recruiting
Madrid, Spain, 28041
Pfizer Investigational Site Recruiting
Malaga, Spain, 29009
Pfizer Investigational Site Recruiting
Santiago de Compostela, Spain, 15705
Pfizer Investigational Site Terminated
Sevilla, Spain, 41014
Pfizer Investigational Site Recruiting
Sevilla, Spain, 41009
Pfizer Investigational Site Terminated
Valencia, Spain, 46026
Sweden
Pfizer Investigational Site Completed
Falun, Sweden, 791 82
Pfizer Investigational Site Recruiting
Jonkoping, Sweden, 55185
Pfizer Investigational Site Recruiting
Jonkoping, Sweden, 551 85
Pfizer Investigational Site Recruiting
Malmo, Sweden, 205 02
Pfizer Investigational Site Recruiting
Sundsvall, Sweden, 851 86
Pfizer Investigational Site Recruiting
Umea, Sweden, 901 85
Pfizer Investigational Site Recruiting
Uppsala, Sweden, 75185
Taiwan
Pfizer Investigational Site Recruiting
Niao Sung Hsiang, Kaohsiung County, Taiwan, 833
Pfizer Investigational Site Completed
Changhua, Taiwan, 500
Pfizer Investigational Site Recruiting
Kaohsiung, Taiwan, 833
Pfizer Investigational Site Recruiting
Kaohsiung, Taiwan, 813
Pfizer Investigational Site Recruiting
Kaohsiung, Taiwan, 807
Pfizer Investigational Site Recruiting
Kaohsiung County, Taiwan, 83301
Pfizer Investigational Site Recruiting
Kwei-Shan, Taiwan, 333
Pfizer Investigational Site Completed
Taichung, Taiwan, 40705
Pfizer Investigational Site Recruiting
Tainan, Taiwan
Pfizer Investigational Site Recruiting
Taipei, Taiwan, 11217
Pfizer Investigational Site Recruiting
Taipei, Taiwan, 10018
Thailand
Pfizer Investigational Site Recruiting
Phayathai, Bangkok, Thailand, 10400
Pfizer Investigational Site Recruiting
Amphoe Mueang, Chiang Mai, Thailand, 50200
Pfizer Investigational Site Recruiting
Bangkok, Thailand, 10400
Pfizer Investigational Site Recruiting
Bangkok, Thailand, 10700
Pfizer Investigational Site Recruiting
Khon Kaen, Thailand, 40002
Turkey
Pfizer Investigational Site Completed
Ankara, Turkey, 06100
Pfizer Investigational Site Recruiting
Izmir, Turkey, 35340
Pfizer Investigational Site Completed
Izmir, Turkey, 35100
Ukraine
Pfizer Investigational Site Recruiting
Simferopol, Crimea, Ukraine, 95017
Pfizer Investigational Site Recruiting
Kharkiv, Ukraine, 61178
Pfizer Investigational Site Recruiting
Kyiv, Ukraine, 04114
Pfizer Investigational Site Recruiting
Kyiv, Ukraine, 04053
Pfizer Investigational Site Recruiting
Lviv, Ukraine, 79011
Pfizer Investigational Site Recruiting
Odesa, Ukraine, 65026
Pfizer Investigational Site Recruiting
Vinnitsa, Ukraine, 21018
Pfizer Investigational Site Recruiting
Zaporizhzhia, Ukraine, 69118
United Kingdom
Pfizer Investigational Site Not yet recruiting
Liverpool, Merseyside, United Kingdom, L9 7AL
Pfizer Investigational Site Recruiting
Wirral, Merseyside, United Kingdom, CH49 5PE
Pfizer Investigational Site Recruiting
Cannock, Mid Staffordshire, United Kingdom, WS11 2XY
Pfizer Investigational Site Recruiting
Dudley, United Kingdom, DY1 2HQ
Pfizer Investigational Site Recruiting
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00413699     History of Changes
Other Study ID Numbers: A3921024
Study First Received: December 18, 2006
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
long-term
open-label
safety

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014