Study Evaluating CCI-779 in Active Rheumatoid Arthritis o... | NCT00076206

Studies
Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy

NCT00076206

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Terminated

Last Update Posted

Dec 9, 2015Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Rheumatoid Arthritis

Interventions

CCI-779
Placebo

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

Dec 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Dec 2003

Primary Completion Date

Aug 2005Actual

Completion Date

Aug 2005Actual

First Submitted Date

Jan 15, 2004

First Submission Date that Met QC Criteria

Jan 16, 2004

First Posted Date

Jan 19, 2004Estimated

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

Dec 7, 2015

Last Update Posted Date

Dec 9, 2015Estimated

Description Module

Brief Summary

The primary objective of this study is to compare the therapeutic response and safety of 3 oral dose levels of CCI-779, with placebo in subjects with active rheumatoid arthritis (RA) who have been receiving stable doses of methotrexate (MTX) for at least 8 weeks.

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

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	CCI-779 1 mg dose to be taken orally daily up to 12 weeks.	Drug: CCI-779
B	Experimental	CCI-779 2 mg dose to be taken orally daily up to 12 weeks.	Drug: CCI-779
C	Experimental	CCI-779 4 mg dose to be taken orally daily up to 12 weeks.	Drug: CCI-779
D	Placebo Comparator	Placebo dose to be taken orally daily up to 12 weeks.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CCI-779	Drug		A B C
Placebo

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meet American College of Rheumatology (ACR) criteria for RA
Have active RA consisting of ≥ 6 swollen and ≥ 6 painful joints
ACR functional class I-III

Exclusion Criteria

At screening the subject's prior medications are reviewed. (Prior history of disease-modifying antirheumatic drug (DMARD) use is recorded, including the start and stop dates of the most recently taken DMARDs)
Significant concurrent medical diseases
Abnormal chest radiograph, including findings consistent with interstitial pneumonitis, granulomatous disease, or pleural effusion and/or infiltration

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 Monitor, MD	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Not provided

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

Intervention Browse Module

MeSH Terms

ID	Term
C401859	temsirolimus

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided