NCT00076206

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2003

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

January 15, 2004

Last Update Submit

December 7, 2015

Conditions

Rheumatoid Arthritis

Study Arms (4)

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

CCI-779DRUG
ABC
PlaceboDRUG
D

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 15, 2004

First Posted

January 19, 2004

Study Start

December 1, 2003

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

December 9, 2015

Record last verified: 2015-12