Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis - Full Text View

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:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Methotrexate sodium Etanercept

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565409

Show 80 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
TNFR-Fc fusion protein
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions

Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on June 17, 2013

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