A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

NCT00550446 | Completed Phase 2 Results

• 1 other identifier: A3921035
• Study Type: interventional
• Target: 386
• Locations: 15 countries
• Sites: 63

Brief Summary

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)

Conditions

Arthritis, Rheumatoid

Keywords

Janus Kinase 3 Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

  ACR20 response: greater than or equal to (\>=) 20 % improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); 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).

  Week 12

Secondary Outcomes (30)

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

  Week 2, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET)

• Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response

  Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

• Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

  Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

• Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response

  Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

• Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve

  Baseline up to Week 2, 4, 6, 8, 10, 12

Other Outcomes (8)

• Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels

  Baseline, Week 24/ ET

• Change From Baseline in Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels at Week 24

  Baseline, Week 24/ ET

• Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers

  Baseline, Week 24/ ET

Study Arms (7)

1

ACTIVE COMPARATOR

Drug: Adalimumab

2

EXPERIMENTAL

Drug: CP-690-550

3

EXPERIMENTAL

Drug: CP-690-550

4

EXPERIMENTAL

Drug: CP-690-550

5

EXPERIMENTAL

Drug: CP-690,550

6

EXPERIMENTAL

Drug: CP-690,550

7

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Adalimumab DRUG

40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.

1

CP-690,550 DRUG

3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)

5

Placebo DRUG

Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)

7

Eligibility Criteria

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

You may qualify if:

• Subjects must have active rheumatoid arthritis
• Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)
• Subjects must not be currently taking any DMARD other than an antimalarial

You may not qualify if:

• Subjects who discontinued any previous TNF inhibitor therapy for either lack of benefit or safety.
• Subjects who previously received adalimumab (Humira®) therapy for any reason.
• Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis

Sponsors & Collaborators

• Pfizer: lead

Study Sites (63)

Pfizer Investigational Site

Mesa, Arizona, 85208, United States

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Little Rock, Arkansas, 72205, United States

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Northridge, California, 91325, United States

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Palo Alto, California, 94304, United States

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Stanford, California, 94305, United States

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Tarzana, California, 91356, United States

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Upland, California, 91786, United States

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Orlando, Florida, 32804, United States

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Tampa, Florida, 33614, United States

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Morton Grove, Illinois, 60053, United States

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Rockford, Illinois, 61107, United States

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Cedar Rapids, Iowa, 52401-2112, United States

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Wichita, Kansas, 67203, United States

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Wichita, Kansas, 67208, United States

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New Orleans, Louisiana, 70115, United States

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Hickory, North Carolina, 28601, United States

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Hickory, North Carolina, 28602, United States

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Dayton, Ohio, 45408, United States

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Duncansville, Pennsylvania, 16635, United States

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Knoxville, Tennessee, 37909-1600, United States

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Dallas, Texas, 75235, United States

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Mesquite, Texas, 75150, United States

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

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São Paulo, São Paulo, 01323-903, Brazil

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Pleven, 5800, Bulgaria

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Sofia, 1612, Bulgaria

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Sofia, 1709, Bulgaria

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Sofia, Bulgaria

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Santiago, RM, 8331030, Chile

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Santiago, RM, 8360156, Chile

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Providencia, Santiago, RM, 7530206, Chile

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Split, 21000, Croatia

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Zagreb, 10000, Croatia

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Brno, 656 91, Czechia

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Prague, 128 50, Czechia

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Prague, 140 59, Czechia

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Praha 11 - Chodov, 148 00, Czechia

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Zlín, 760 01, Czechia

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Dresden, 01067, Germany

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Hamburg, 22081, Germany

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Hildesheim, 31134, Germany

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Leipzig, 04103, Germany

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Goudi, Athens, 11527, Greece

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Thessaloniki, 54 636, Greece

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Szolnok, H-5000, Hungary

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Florence, 50139, Italy

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Genova, 16132, Italy

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México, D.f., 06100, Mexico

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Guadalajara, Jalisco, 44650, Mexico

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Cuernavaca, Morelos, 62270, Mexico

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Metepec, State of Mexico, 52140, Mexico

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Constanța, Constanța County, 900591, Romania

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Iași, Iaşi, 700661, Romania

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Bucharest, 011172, Romania

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Piešťany, 921 12, Slovakia

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Žilina, 012 07, Slovakia

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Seoul, 110-744, South Korea

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Seoul, 133-792, South Korea

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Kharkiv, 61000, Ukraine

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Kyiv, 04114, Ukraine

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Lviv, 79011, Ukraine

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Vinnitsa, 21018, Ukraine

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Zaporizhzhia, 69118, Ukraine

Location

Related Publications (17)

• 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

• 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.

  PMID: 37453736 DERIVED

• 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

• 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

• 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

• Suzuki M, Shoji S, Miyoshi S, Krishnaswami S. Model-Based Comparison of Dose-Response Profiles of Tofacitinib in Japanese Versus Western Rheumatoid Arthritis Patients. J Clin Pharmacol. 2020 Feb;60(2):198-208. doi: 10.1002/jcph.1514. Epub 2019 Sep 12.

  PMID: 31512746 DERIVED

• Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.

  PMID: 28941219 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

• Wallenstein GV, Kanik KS, Wilkinson B, Cohen S, Cutolo M, Fleischmann RM, Genovese MC, Gomez Reino J, Gruben D, Kremer J, Krishnaswami S, Lee EB, Pascual-Ramos V, Strand V, Zwillich SH. Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials. Clin Exp Rheumatol. 2016 May-Jun;34(3):430-42. Epub 2016 Apr 28.

  PMID: 27156561 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, Cutolo M, Genovese MC, Lee EB, Kanik KS, Sadis S, Connell CA, Gruben D, Krishnaswami S, Wallenstein G, Wilkinson BE, Zwillich SH. Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. Arthritis Rheum. 2012 Mar;64(3):617-29. doi: 10.1002/art.33383.

  PMID: 21952978 DERIVED

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab; tofacitinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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 2
• 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: October 25, 2007
• First Posted: October 29, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: January 3, 2013
• Results First Posted: January 3, 2013

Record last verified: 2012-11

Locations

GR (2); CZ (5); CR (2); HU (1); IT (2); BR (2); DE (4); RO (3); SL (2); US (22); BU (4); KR (2); UA (5); CL (3); ME (4)