Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate (SERUM)

Pfizer

Status and phase: Terminated; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Etanercept; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01783015

B1801355

2012-003644-71 (EudraCT Number)

Details and patient eligibility

About

The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.

Full description

This study was prematurely terminated on June 25, 2014 due to significant and continuing delays in achieving the study B1801355 enrolment target. The decision to stop the study was not driven by any safety concerns.

Enrollment: 16 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Met the 1987 ACR Revised Criteria for RA
2. A history of inadequate response to infliximab or adalimumab in combination with methotrexate.
3. A stable dose of oral methotrexate for at least 6 weeks before the baseline visit.

Exclusion criteria

1. ACR functional class IV
2. Prior treatment with etanercept; both infliximab and adalimumab; or any immunosuppressive biologic agent other than infliximab or adalimumab.
3. Discontinuation of infliximab or adalimumab for a primary reason other than inadequate efficacy response.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 4 patient groups, including a placebo group

Group A

Experimental group

Description:

Subjects who are mAb ADA positive

Treatment:

Drug: Etanercept

Group B

Experimental group

Description:

Subjects who are mAb ADA negative

Treatment:

Drug: Etanercept

Group C

Placebo Comparator group

Description:

Subjects who are mAb ADA positive

Treatment:

Drug: Placebo

Group D

Placebo Comparator group

Description:

Subjects who are mAb ADA negative

Treatment:

Drug: Placebo