A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

NCT00814307 | Completed Phase 3 Results DMC

• 1 other identifier: A3921045
• Study Type: interventional
• Target: 611
• Locations: 16 countries
• Sites: 95

Brief Summary

This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 Rheumatoid Arthritis studies.

Conditions

Arthritis, Rheumatoid

Keywords

Antirheumatic Agents Clinical Trial

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3

  ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

  Month 3

• Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3

  HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional 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, 0=least functional difficulty and 3=extreme functional difficulty.

  Baseline, Month 3

• Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3

  DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=\<) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6=remission.

  Month 3

Secondary Outcomes (40)

• Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2

  Week 2, Month 1, 2

• Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6

  Month 4, 5, 6

• Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3

  Week 2, Month 1, 2, 3

• Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6

  Month 4, 5, 6

• Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3

  Week 2, Month 1, 2, 3

Other Outcomes (2)

• Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain

  2 weeks

• Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis

  2 weeks

Study Arms (4)

Active 5mg

EXPERIMENTAL

Drug: CP-690,550

Active 10 mg

EXPERIMENTAL

Drug: CP-690,550

Placebo Sequence 1

PLACEBO COMPARATOR

Drug: Placebo

Placebo Sequence 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CP-690,550 DRUG

5mg CP-690,550 BID PO for 6 months

Active 5mg

Placebo DRUG

Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit

Placebo Sequence 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
• The patient has active disease at both Screening and Baseline, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) \>28 mm in the local laboratory. 2. CRP \>7 mg/L in the central laboratory
• Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
• Patient has washed out of all DMARDs other that antimalarials

You may not qualify if:

• Blood dyscrasias including confirmed: 1. Hemoglobin \<9 g/dL or Hematocrit \<30%; 2. White blood cell count \<3.0 x 109/L; 3. Absolute neutrophil count \<1.2 x 109/L; 4. Platelet count \<100 x 109/L
• History of any other autoimmune rheumatic disease other than Sjogren's syndrome
• No malignancy or history of malignancy.
• History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug

Sponsors & Collaborators

• Pfizer: lead

Study Sites (95)

Pfizer Investigational Site

Gilbert, Arizona, 85234, United States

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Tucson, Arizona, 85704, United States

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Hot Springs, Arkansas, 71913, United States

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Jacksonville, Florida, 32216, United States

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Sarasota, Florida, 34233, United States

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Tampa, Florida, 33614, United States

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Venice, Florida, 34292, United States

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Zephyrhills, Florida, 33542, United States

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Rockford, Illinois, 61107, United States

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Frederick, Maryland, 21702, United States

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Hyannis, Massachusetts, 02763, United States

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Kalamazoo, Michigan, 49048, United States

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Teaneck, New Jersey, 07666, United States

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Albany, New York, 12206, United States

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Olean, New York, 14760, United States

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Rochester, New York, 14618, United States

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Charlotte, North Carolina, 28210, United States

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Rocky Mount, North Carolina, 27803, United States

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Winston-Salem, North Carolina, 27103, United States

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Minot, North Dakota, 58701, United States

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Dayton, Ohio, 45408, United States

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Bethlehem, Pennsylvania, 18015, United States

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Duncansville, Pennsylvania, 16635, United States

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West Reading, Pennsylvania, 19611-1124, United States

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Greenville, South Carolina, 29601, United States

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Myrtle Beach, South Carolina, 29572, United States

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Dallas, Texas, 75231, United States

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Mesquite, Texas, 75150, United States

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Seattle, Washington, 98104, United States

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Seattle, Washington, 98122, United States

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Clarksburg, West Virginia, 26301, United States

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Goiânia, Goiás, 74110-120, Brazil

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Curitiba, Paraná, 80060-240, Brazil

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Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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São Paulo, São Paulo, 04266-010, Brazil

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São Paulo, São Paulo, 05437-010, Brazil

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Pleven, 5800, Bulgaria

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Plovdiv, 4000, Bulgaria

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Plovdiv, 4002, Bulgaria

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Sofia, 1606, Bulgaria

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Sofia, 1709, Bulgaria

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Santiago, RM, 7510186, Chile

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Santiago, RM, 8360156, Chile

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Providencia, Santiago, RM, 7530206, Chile

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Bucaramanga, Santander Department, Colombia

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Barranquilla, Colombia

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Brno, 625 00, Czechia

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Česká Lípa, 470 01, Czechia

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Hlučín, 748 01, Czechia

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Pardubice, 530 02, Czechia

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Prague, 128 50, Czechia

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Prague, 140 00, Czechia

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Prague, 140 59, Czechia

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Zlín, 760 01, Czechia

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Santo Domingo, Santo Domingo Province, 00000, Dominican Republic

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Berlin, 14059, Germany

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Halle, 06108, Germany

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Hamburg, 22081, Germany

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Leipzig, 04103, Germany

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München, 80336, Germany

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Nuremberg, 90429, Germany

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Hyderabad, Andhra Pradesh, 500 004, India

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Secunderabad, Andhra Pradesh, 500 003, India

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Ahmedabad, Gujarat, 380 015, India

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Bangalore, Karnataka, 560 001, India

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Bangalore, Karnataka, 560 034, India

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Bangalore, Karnataka, 560 079, India

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Mangalore, Karnataka, 575 001, India

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Mangalore, Karnataka, 575002, India

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Pune, Maharashtra, 411 001, India

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Putrajaya, Kuala Lumpur, 62250, Malaysia

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Kota Kinabalu, Sabah, 88586, Malaysia

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Kuching, Sarawak, 93586, Malaysia

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Petaling Jaya, Selangor, 46150, Malaysia

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Chihuahua City, Chihuahua, 31000, Mexico

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Tijuana, Estado de Baja California, 22010, Mexico

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Guadalajara, Jalisco, 44620, Mexico

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Monterrey, Nuevo León, 64020, Mexico

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Dasmariñas, Cavite, 4114, Philippines

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Bajada, Davao City, Phlippines, 8000, Philippines

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Las Piñas, 1742, Philippines

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Manila, 1008, Philippines

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Warsaw, 02-256, Poland

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Wroclaw, 50-088, Poland

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San Juan, 00918, Puerto Rico

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Petrozavodsk, 185019, Russia

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Smolensk, 214019, Russia

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Kharkiv, 61178, Ukraine

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Kyiv, 04114, Ukraine

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Lviv, 79011, Ukraine

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Pfizer Investigational Site

Simferopol, Crimea, 95017, Ukraine

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Pfizer Investigational Site

Vinnitsa, 21018, Ukraine

Location

Related Publications (22)

• Hetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9.

  PMID: 39192350 DERIVED

• Wright GC, Mysler E, Kwok K, Cadatal MJ, Germino R, Yndestad A, Kinch CD, Ogdie A. Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials. Rheumatol Ther. 2024 Oct;11(5):1135-1164. doi: 10.1007/s40744-024-00677-y. Epub 2024 Jul 3.

  PMID: 38958913 DERIVED

• Pope J, Finckh A, Silva-Fernandez L, Mandl P, Fan H, Rivas JL, Valderrama M, Montoro M. Tofacitinib Monotherapy in Rheumatoid Arthritis: Clinical Trials and Real-World Data Contextualization of Patients, Efficacy, and Treatment Retention. Open Access Rheumatol. 2024 Jun 11;16:115-126. doi: 10.2147/OARRR.S446431. eCollection 2024.

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• Citera G, Jain R, Irazoque F, Madariaga H, Gruben D, Wang L, Stockert L, Santana K, Ebrahim A, Ponce de Leon D. Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety: Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials. Rheumatol Ther. 2024 Feb;11(1):35-50. doi: 10.1007/s40744-023-00612-7. Epub 2023 Nov 5.

  PMID: 37925660 DERIVED

• Charles-Schoeman C, Hyde C, Guan S, Parikh N, Wang J, Shahbazian A, Stockert L, Andrews J. Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis Receiving Tofacitinib. J Rheumatol. 2023 Jul 15:jrheum.2023-0112. doi: 10.3899/jrheum.2023-0112. Online ahead of print.

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• Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.

  PMID: 36931693 DERIVED

• Dougados M, Taylor PC, Bingham CO 3rd, Fallon L, Brault Y, Roychoudhury S, Wang L, Kessouri M. The effect of tofacitinib on residual pain in patients with rheumatoid arthritis and psoriatic arthritis. RMD Open. 2022 Sep;8(2):e002478. doi: 10.1136/rmdopen-2022-002478.

  PMID: 36814062 DERIVED

• Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.

  PMID: 36601090 DERIVED

• Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.

  PMID: 36600185 DERIVED

• Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.

  PMID: 36526796 DERIVED

• Dikranian AH, Gonzalez-Gay MA, Wellborne F, Alvaro-Gracia JM, Takiya L, Stockert L, Paulissen J, Shi H, Tatulych S, Curtis JR. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies. RMD Open. 2022 May;8(1):e002103. doi: 10.1136/rmdopen-2021-002103.

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• Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.

  PMID: 34921355 DERIVED

• Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

  PMID: 34870800 DERIVED

• Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.

  PMID: 33127856 DERIVED

• Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.

  PMID: 32816215 DERIVED

• Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19.

  PMID: 30177460 DERIVED

• Bird P, Bensen W, El-Zorkany B, Kaine J, Manapat-Reyes BH, Pascual-Ramos V, Witcombe D, Soma K, Zhang R, Thirunavukkarasu K. Tofacitinib 5 mg Twice Daily in Patients with Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs: A Comprehensive Review of Phase 3 Efficacy and Safety. J Clin Rheumatol. 2019 Apr;25(3):115-126. doi: 10.1097/RHU.0000000000000786.

  PMID: 29794874 DERIVED

• Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

  PMID: 28143815 DERIVED

• Strand V, Kremer J, Wallenstein G, Kanik KS, Connell C, Gruben D, Zwillich SH, Fleischmann R. Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs. Arthritis Res Ther. 2015 Nov 4;17:307. doi: 10.1186/s13075-015-0825-9.

  PMID: 26530039 DERIVED

• Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14.

  PMID: 26275429 DERIVED

• Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.

  PMID: 25047021 DERIVED

• Fleischmann R, Kremer J, Cush J, Schulze-Koops H, Connell CA, Bradley JD, Gruben D, Wallenstein GV, Zwillich SH, Kanik KS; ORAL Solo Investigators. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012 Aug 9;367(6):495-507. doi: 10.1056/NEJMoa1109071.

  PMID: 22873530 DERIVED

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 24, 2008
• Study Start: February 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 18, 2013
• Results First Posted: January 11, 2013

Record last verified: 2013-01

Locations

BU (5); PL (2); CZ (8); ME (4); RU (2); US (31); CL (3); DO (1); IN (9); CO (2); BR (8); UA (5); DE (6); PR (1); PH (4); MY (4)