A Study of the Safety, Pharmacokinetics, and Pharmacodyna... | NCT00718588

Studies
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis

NCT00718588

Sponsor

Genentech, Inc.

Status

Terminated

Last Update Posted

Mar 7, 2012Estimated

Enrollment

66Actual

Phase

Phase 1

Conditions

Rheumatoid Arthritis

Interventions

MTRX1011A

Countries

Not provided

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

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study had completed enrollment but drug injection was halted due to an unacceptable incidence of rash.

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Not provided

First Submitted Date

Jul 16, 2008

First Submission Date that Met QC Criteria

Jul 16, 2008

First Posted Date

Jul 18, 2008Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2012

Last Update Posted Date

Mar 7, 2012Estimated

Description Module

Brief Summary

This is a Phase I multicenter study that will be conducted in the United States and consists of a double-blind, placebo-controlled, SAD stage, followed by a double-blind, placebo controlled MAD stage. The study will be conducted in approximately 65 adult patients between 18 and 80 years old who have RA.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Name	Type	Description	Arm Group Labels	Other Names
MTRX1011A	Drug	Subcutaneous and intravenous single and repeating dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of MTRX1011A in both the SAD and MAD stages		Length of study

Secondary Outcomes

Measure	Description	Time Frame
Characterize the pharmacokinetic response of MTRX1011A		Length of study
Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A		Length of study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

SAD Stage
- RA diagnosed according to the ACR
- For patients taking anti-rheumatic therapies, receipt of a stable regimen prior to randomization
- Previous treatment with biologic agents, including anti-TNF agents, permitted but discontinued for an appropriate washout period
MAD Stage (same as above with the addition of the following)
- Failure of at least one biologic agent, defined as lack of or loss of response or intolerance
- Active disease defined by swollen and tender count

Exclusion Criteria:

Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty's syndrome
Malignancy, or prior malignancy, other than non-melanoma skin cancer or cervical carcinoma in situ that has been resected
History of treatment with any T cell-directed therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
John Davis, M.D., M.P.H.	Genentech, Inc.	Study Director

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