Clinical trial NCT00099554: Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)
Official title: A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-12-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the proportion of Rheumatoid Arthritis (RA) subjects achieving a "good" or "moderate" DAS28 response (EULAR28 criteria) at Week 16 with etanercept 50 mg subcutaneously (SC) once weekly in patients who have failed infliximab.


Eligibility criteria: Inclusion Criteria:

* Adults with RA (ACR criteria) for greater than or equal to 6 months
* Infliximab treatment for at least 18 weeks
* Infliximab infusion prior to screening at an increased dosing regimen: 5 mg/kg every 4-8 weeks (dose), OR, 3 mg/kg every 4-6 weeks (frequency)
* Failing infliximab defined by ALL of the following at screening and baseline visit: Disease Activity Score (DAS 28) greater than or equal to 4.5, greater than or equal to 5 swollen joints, greater than or equal to 5 tender joints
* Subjects must be receiving stable methotrexate (MTX), at a dose of greater than or equal to 10 mg/week at least 10 weeks prior to screening
* Stable disease modifying anti-rheumatic drugs (DMARD) therapy (including sulfasalazine, hydroxychloroquine), greater than or equal to 8 weeks prior to screening
* Stable dose corticosteroids, less than 10 mg/day at greater than or equal to 4 weeks prior to screening
* Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) greater than or equal to 1 week prior to screening

Exclusion Criteria:

* ACR functional class IV - Prior treatment with etanercept
* Receipt of any investigational drug/biologic within 28 days of study drug initiation
* Active infection or predisposition to infection
* Elective surgery planned during study period
* Intra-articular, soft tissue, or intramuscular corticosteroid injections during 4 weeks prior to screening
* Contraindications to etanercept as defined in the package insert
* Severe co-morbidities: History of cancer within 5 years; Diagnosis of class III or IV congestive heart failure (CHF); Uncontrolled hypertension (HTN); CNS-demyelinating events suggestive of multiple sclerosis (MS); Known HIV-positive status; Oxygen-dependent pulmonary status; Chronic hepatitis B or C; Systemic Lupus Erythematosus (SLE); Active or prior history of tuberculosis (TB) (or known exposure) or positive PPD without adequate TB prophylaxis

Primary outcomes:
measure: Proportion of subjects achieving a "good" or "moderate" DAS28 response (as defined by EULAR28 criteria) at Week 16.
Secondary outcomes:
measure: Proportion of subjects who achieve ACR 20, 50, and 70 responses at Weeks 8 and 16.
measure: Proportion of subjects who achieve good or moderate DAS28 response at Week 8 and the proportion who achieve remission (DAS28 less than 2.6) at Weeks 8 and 16
measure: Absolute and percent changes from baseline in components of the ACR and DAS28 criteria (including HAQ) at Weeks 8 and 16.
measure: Absolute changes from baseline in SF-36 and Valued Life Activities at Weeks 8 and 16
measure: Subject incidence rate of SAEs over 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Bingham CO 3rd, Ince A, Haraoui B, Keystone EC, Chon Y, Baumgartner S. Effectiveness and safety of etanercept in subjects with RA who have failed infliximab therapy: 16-week, open-label, observational study. Curr Med Res Opin. 2009 May;25(5):1131-42. doi: 10.1185/03007990902841010.