You are here

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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00076206
Pfizer
Terminated
Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Systemic Lupus Erythematosus, Rheumatoid Arthritis
NCT03334851
All Genders
18+
Years
Multiple Sites
Hip Osteoarthritis, Knee Osteoarthritis
NCT02709486
All Genders
18+
Years
Multiple Sites
Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy
A Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Oral Dose Levels (1, 2, And 4 Mg) of CCI-779 in Subjects With Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: CCI-779
  • Drug: Placebo
  • Experimental: A
    CCI-779 1 mg dose to be taken orally daily up to 12 weeks.
    Intervention: Drug: CCI-779
  • Experimental: B
    CCI-779 2 mg dose to be taken orally daily up to 12 weeks.
    Intervention: Drug: CCI-779
  • Experimental: C
    CCI-779 4 mg dose to be taken orally daily up to 12 weeks.
    Intervention: Drug: CCI-779
  • Placebo Comparator: D
    Placebo dose to be taken orally daily up to 12 weeks.
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
August 2005
August 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00076206
3066A3-206
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now