A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
NCT00938587
Last updated date
ABOUT THIS STUDY
This study will investigate the safety and efficacy of an investigational drug, PF-04171327
on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids
while on background methotrexate. This study will also look at the response of chemical and
biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK
(amount of drug in the blood) of methotrexate while patients may be taking PF-04171327.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
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
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Patients ≥ 18 years of age, diagnosed with rheumatoid arthritis for a minimum duration of 3 months
- On stable dose of methotrexate for at least 6 weeks prior to screening
- Patient must have minimum disease activity level of ≥ 6 tender/painful joints, ≥ 6 swollen joints and CRP ≥ 0.7 mg/dL
- Not currently receiving steroid medication
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Pregnant or nursing women
- Patients that have active infections, TB, HIV and/or Hepatitis B or C
- Patients that have a history of intolerance or significant adverse effects with the
use of glucocorticoids
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis | |||
| Official Title ICMJE | A Phase 2a, Randomized, Double-Blind, Active And Placebo-Controlled Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis | |||
| Brief Summary | This study will investigate the safety and efficacy of an investigational drug, PF-04171327 on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids while on background methotrexate. This study will also look at the response of chemical and biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK (amount of drug in the blood) of methotrexate while patients may be taking PF-04171327. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE | Rheumatoid Arthritis | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 86 | |||
| Original Estimated Enrollment ICMJE | 80 | |||
| Actual Study Completion Date ICMJE | July 2010 | |||
| Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Czechia, Hong Kong, Hungary, Korea, Republic of, Russian Federation, Serbia, Singapore, Slovakia, Spain, Taiwan, Turkey, Ukraine, United States | |||
| Removed Location Countries | Czech Republic | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00938587 | |||
| Other Study ID Numbers ICMJE | A9391005 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | November 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||