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

November 28, 2007
February 7, 2012
December 2007
May 2011   (final data collection date for primary outcome measure)
Disease Activity Score (DAS28) over 88 weeks. [ Time Frame: 88 weeks ] [ Designated as safety issue: No ]
Disease Activity Score (DAS28) over 88 weeks. [ Time Frame: 88 weeks ]
Complete list of historical versions of study NCT00565409 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • 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).

  • Drug: Etanercept
    Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.
  • Drug: Placebo
    Subcutaneous (SC), once weekly from week 36 to week 88.
  • Active Comparator: 1
    Interventions:
    • Drug: Etanercept
    • Drug: Methotrexate
  • Active Comparator: 2
    Interventions:
    • Drug: Etanercept
    • Drug: Methotrexate
  • Placebo Comparator: 3
    Interventions:
    • Drug: Placebo
    • Drug: Methotrexate
Smolen JS, Nash P, Durez P, Hall S, Ilivanova E, Irazoque-Palazuelos F, Miranda P, Park MC, Pavelka K, Pedersen R, Szumski A, Hammond C, Koenig AS, Vlahos B. Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial. Lancet. 2013 Mar 16;381(9870):918-29. doi: 10.1016/S0140-6736(12)61811-X. Epub 2013 Jan 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
834
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Chile,   Colombia,   Czech Republic,   Former Serbia and Montenegro,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom
 
NCT00565409
0881A1-4423, B1801003
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP