BG9924 in Combination With Methotrexate for Participants... | NCT00458861

Studies
BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis

NCT00458861

Sponsor

Biogen

Status

Terminated

Last Update Posted

Jan 21, 2016Estimated

Enrollment

115Actual

Phase

Phase 2

Conditions

Rheumatoid Arthritis

Interventions

BG9924
Placebo Comparator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006-005467-26	EudraCT Number

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Interim analysis of data failed to meet primary endpoint.

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Mar 22, 2007

First Submission Date that Met QC Criteria

Apr 9, 2007

First Posted Date

Apr 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Dec 17, 2015

Certification/Extension First Submitted that Passed QC Review

Dec 17, 2015

Certification/Extension First Posted Date

Jan 21, 2016Estimated

Last Update Submitted Date

Dec 17, 2015

Last Update Posted Date

Jan 21, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BG9924	Experimental	Subcutaneous administration of BG9924 given every other week for 12 weeks	Biological: BG9924
Placebo	Placebo Comparator	Subcutaneous administration of placebo given every other week for 12 weeks	Other: Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BG9924	Biological	Subcutaneous administration of BG9924 given every other week for 12 weeks	BG9924

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy		26 weeks

Secondary Outcomes

Measure	Description	Time Frame
Assess the safety and tolerability of BG9924 in this participant population.		26 weeks
Assess the pharmacokinetic and pharmacodynamic profile of BG9924 in this participant population.		26 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Diagnosis of rheumatoid arthritis (functional class I - III) at least 6 months prior to baseline
Methotrexate (10 mg/week to 25 mg/week) > 3 months prior to Day 0 (stable dose > 4 weeks prior to Day 0)
Must have had an inadequate response to anti-TNF therapy due to inadequate efficacy

Key Exclusion Criteria:

Medical History

Serious local infection or systemic infection within 3 months of Day 0
History (Hx) of recurrent infections requiring oral or parental anti-infective treatment
Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period

Laboratory Tests

Clinically significant lab tests at screening; or
Positive for hepatitis C antibody or hepatitis B at screening

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Director	Biogen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Palo Alto	California	93404	United States

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided