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Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis (PRESERVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00565409
First received: November 28, 2007
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: Etanercept
Drug: Methotrexate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Disease Activity Score (DAS28) over 88 weeks. [ Time Frame: 88 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving low disease activity or remission at each visit during period 1 and period 2. [ Time Frame: Week 1 to Week 88 ] [ Designated as safety issue: No ]
  • Change in the DAS28 during period 1 and period 2 at each visit. [ Time Frame: Week 1 to Week 88 ] [ Designated as safety issue: No ]
  • Time to loss of low disease activity (DAS28 >3.2) and a change of ≥0.6 in the DAS28 during period 2. [ Time Frame: Week 36 to Week 88 ] [ Designated as safety issue: No ]
  • Time to loss of low disease activity (DAS28 >3.2) during period 2. [ Time Frame: Week 36 to Week 88 ] [ Designated as safety issue: No ]
  • Proportion of time subjects have low disease activity. [ Time Frame: Week 1 to Week 88 ] [ Designated as safety issue: No ]
  • Change in the painful and swollen joint counts during period 1 and period 2 at each visit. [ Time Frame: Week 1 to Week 88 ] [ Designated as safety issue: No ]
  • Change in the physician global assessments during period 1 and period 2 at each visit. [ Time Frame: Week 1 to Week 88 ] [ Designated as safety issue: No ]
  • Change in the subject global assessments, including morning stiffness (measured in minutes), during period 1 and period 2 at each visit. [ Time Frame: Week 1 to Week 88 ] [ Designated as safety issue: No ]
  • Change in the general health Visual Analog Scale (VAS), and pain VAS during period 1 and period 2 at each visit. [ Time Frame: Week 1 to Week 88 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving an acceptable state on the Patient Acceptable Symptom State (PASS) at various visits. [ Time Frame: Week 1, 36, 64 and 88 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving European League Against Rheumatism (EULAR) good or moderate responses during period 1 and period 2 at each visit. [ Time Frame: Week 1 to Week 88 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 during period 1 and period 2 at each visit. [ Time Frame: Week 1 to Week 88 ] [ Designated as safety issue: No ]

Enrollment: 834
Study Start Date: December 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Etanercept
Subcutaneous (SC), 50 mg, once weekly for 88 weeks
Other Name: Enbrel
Drug: Methotrexate

Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.

If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).

Active Comparator: 2 Drug: Etanercept
Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.
Drug: Methotrexate

Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.

If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).

Placebo Comparator: 3 Drug: Placebo
Subcutaneous (SC), once weekly from week 36 to week 88.
Drug: Methotrexate

Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks.

If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis.
  • Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.
  • Active rheumatoid arthritis at the time of screening.

Exclusion Criteria:

  • Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
  • Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other than MTX within 28 days before baseline.
  • Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.
  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: NCT00565409

  Hide Study Locations
Locations
Australia, New South Wales
Pfizer Investigational Site
Campsie, New South Wales, Australia, 2194
Pfizer Investigational Site
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Pfizer Investigational Site
Maroochydore, Queensland, Australia, 4558
Australia, South Australia
Pfizer Investigational Site
Daw Park, South Australia, Australia, 5041
Australia, Victoria
Pfizer Investigational Site
Heidelberg West, Victoria, Australia, 3081
Pfizer Investigational Site
Malvern, Victoria, Australia, 3145
Australia
Pfizer Investigational Site
Victoria Park, Australia, 6100
Austria
Pfizer Investigational Site
Wien, Austria, 1130
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1200
Pfizer Investigational Site
Liege, Belgium, 4000
Pfizer Investigational Site
Yvoir, Belgium, 5530
Chile
Pfizer Investigational Site
Santiago, Region Metropolitana, Chile
Colombia
Pfizer Investigational Site
Barranquilla, Atlantico, Colombia
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 656 91
Pfizer Investigational Site
Bruntal, Czech Republic, 79201
Pfizer Investigational Site
Bruntal, Czech Republic, 792 01
Pfizer Investigational Site
Praha 2, Czech Republic, 128 50
Pfizer Investigational Site
Praha 5, Czech Republic, 150 06
Pfizer Investigational Site
Zlin, Czech Republic, 760 01
Former Serbia and Montenegro
Pfizer Investigational Site
Belgrade, Former Serbia and Montenegro, 11000
Pfizer Investigational Site
Niska Banja, Former Serbia and Montenegro, 18205
France
Pfizer Investigational Site
Corbeil-Essonnes, France, 91100
Pfizer Investigational Site
Le Kremlin Bicetre, France, 94270
Pfizer Investigational Site
Le Mans, France, 72037
Pfizer Investigational Site
Montpellier, France, 34059
Pfizer Investigational Site
Nice, France, 06202
Pfizer Investigational Site
Paris, France, 75018
Pfizer Investigational Site
Strasbourg, France, 67098
Pfizer Investigational Site
Toulouse, France, 31059
Germany
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Hamburg-Eilbek, Germany, 22081
Pfizer Investigational Site
Koeln, Germany, 50937
Pfizer Investigational Site
Leipzig, Germany, 04103
Pfizer Investigational Site
Leipzig, Germany, 4103
Pfizer Investigational Site
Wuerzburg, Germany, 97080
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1023
Pfizer Investigational Site
Debrecen, Hungary, H-4032
Pfizer Investigational Site
Debrecen, Hungary, 4012
Pfizer Investigational Site
Szombathely, Hungary, 9701
Italy
Pfizer Investigational Site
Catania, CT, Italy, 95100
Pfizer Investigational Site
Orbassano, TO, Italy, 10043
Pfizer Investigational Site
Roma, Italy, 00128
Korea, Republic of
Pfizer Investigational Site
Seo-gu, Daejeon, Korea, Republic of, 302-799
Pfizer Investigational Site
Namdong-gu, Incheon, Korea, Republic of, 405-760
Pfizer Investigational Site
Seoul, Korea, Korea, Republic of, 135-720
Pfizer Investigational Site
Seongdong-gu, Seoul, Korea, Republic of, 133-792
Pfizer Investigational Site
Anyang-si Gyeonggi-do, Korea, Republic of, 431-070
Pfizer Investigational Site
Seoul, Korea, Republic of, 134-701
Pfizer Investigational Site
Seoul, Korea, Republic of, 143-729
Mexico
Pfizer Investigational Site
Merida, Yucatan, Mexico, 97000
Pfizer Investigational Site
Guadalajara, Mexico, 44650
Pfizer Investigational Site
Mexico City, Mexico, 06700
Pfizer Investigational Site
Mexico DF, Mexico, 11500
Pfizer Investigational Site
Monterrey, Mexico, 64020
Pfizer Investigational Site
Queretaro, Mexico, 76000
Netherlands
Pfizer Investigational Site
Heerlen, Netherlands, 6419 PC
Poland
Pfizer Investigational Site
Warszawa, 02-637, Poland
Pfizer Investigational Site
Bydgoszcz, Poland, 85-168
Pfizer Investigational Site
Lodz, Poland, 93-513
Pfizer Investigational Site
Lublin, Poland, 20-954
Pfizer Investigational Site
Szczecin, Poland, 71-252
Russian Federation
Pfizer Investigational Site
Moscow, 119049, Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 115522
Pfizer Investigational Site
Moscow, Russian Federation, 119002
Pfizer Investigational Site
Moscow, Russian Federation, 129110
Pfizer Investigational Site
St Petersburg, Russian Federation, 199004
Pfizer Investigational Site
St. Petersburg, Russian Federation, 194291
Spain
Pfizer Investigational Site
Santiago de Compostela, A Coruña, Spain, 157 06
Pfizer Investigational Site
Sabadell, Barcelona, Spain, 08208
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
La Coruña, Spain, 15006
Pfizer Investigational Site
Malaga, Spain, 29009
Pfizer Investigational Site
Sevilla, Spain, 41009
Sweden
Pfizer Investigational Site
Falun, Sweden, 79182
Pfizer Investigational Site
Oskarström, Sweden, 31392
Taiwan
Pfizer Investigational Site
Tapei City, ROC, Taiwan, 114
Pfizer Investigational Site
Kaohsiung City, Taiwan, 807
United Kingdom
Pfizer Investigational Site
Wigan, Lancashire, United Kingdom, WN6 9EP
Pfizer Investigational Site
Dudley, West Midlands, United Kingdom, DY1 2HQ
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00565409     History of Changes
Other Study ID Numbers: 0881A1-4423, B1801003
Study First Received: November 28, 2007
Last Updated: February 7, 2012
Health Authority: Australia: Human Research Ethics Committee
France: Institutional Ethical Committee
Hungary: Nation

Keywords provided by Pfizer:
Active Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Immunoglobulin G
Methotrexate
TNFR-Fc fusion protein
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014