BG9924 in Combination With Methotrexate Extension of Stud... | NCT00523328

Studies
BG9924 in Combination With Methotrexate Extension of Study 104RA203 (NCT 00458861)

NCT00523328

Sponsor

Biogen

Status

Terminated

Last Update Posted

Jan 21, 2016Estimated

Enrollment

72Actual

Phase

Phase 2

Conditions

Rheumatoid Arthritis

Interventions

BG9924

Countries

United States
Belgium
Canada
United Kingdom

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
2007-000734-38	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

Analysis of data from 104RA203 failed to meet primary endpoint.

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Aug 17, 2007

First Submission Date that Met QC Criteria

Aug 29, 2007

First Posted Date

Aug 31, 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

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

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BG9924	Experimental	dosage administered as per Biogen-idec protocol	Drug: BG9924

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BG9924	Drug	dosage administered as per Biogen-idec protocol	BG9924

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.		The duration of this study is 18 months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be a participant from Study 104RA203 (NCT 00458861)

Exclusion Criteria:

Participants with a significant change in medical history from their previous BG9924 Study 104RA203 (NCT 00458861).
Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study.
Male and female participants of child-bearing potential not willing to practice effective birth control for the duration of the study.

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Director	Biogen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Coordinating Research Site		Palo Alto	California	94305	United States
Coordinating Research Site

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid
D001168	Arthritis

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053308	Lymphotoxin-beta

Ancestor Terms

ID	Term
D048069	Tumor Necrosis Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided