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Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)

Last updated on November 11, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Roma, , 00161 Italy
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 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Eighteen years of age or older

2. Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4
of the following 7 criteria:

1. Morning stiffness in and around the joints lasting at least 1 hour;

2. Arthritis of 3 or more joint areas;

3. Arthritis of hand joints;

4. Symmetric arthritis. simultaneous involvement of the same joint areas on both
sides of the body;

5. Rheumatoid nodules;

6. Serum Rheumatoid Factor (RF)

7. Radiographic changes. Criteria 1 through 4 must have been present for at least 6
weeks.

3. Patients refractory or without complete response to DMARDs according to the Italian
Guidelines for the clinical practice established by Italian Society of Rheumatology

4. Patients naive to anti-TNF drugs

5. Outpatients

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

Patients involved in controlled or interventional trials in the 12 previous months

NCT00794118
Pfizer
Completed
Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)

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Descriptive Information
Brief TitleDrug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)
Official TitleDrug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study
Brief SummaryThe primary purpose of this observational study is to describe and define the current daily practice of management of anti-TNF-agents in Rheumatoid Arthritis (RA) patients. Data will be collected only from subjects providing informed consent.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Populationprimary care clinic
ConditionRheumatoid Arthritis
InterventionOther: As per clinical practice
As per clinical practice
Other Name: Observational study
Study Groups/Cohorts1.0
As per routinary clinical practice
Intervention: Other: As per clinical practice
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 StatusCompleted
Actual Enrollment
 (submitted: June 28, 2011)
299
Original Estimated Enrollment
 (submitted: November 18, 2008)
500
Actual Study Completion DateApril 2011
Actual Primary Completion DateApril 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Eighteen years of age or older
  2. Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4 of the following 7 criteria:

    1. Morning stiffness in and around the joints lasting at least 1 hour;
    2. Arthritis of 3 or more joint areas;
    3. Arthritis of hand joints;
    4. Symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body;
    5. Rheumatoid nodules;
    6. Serum Rheumatoid Factor (RF)
    7. Radiographic changes. Criteria 1 through 4 must have been present for at least 6 weeks.
  3. Patients refractory or without complete response to DMARDs according to the Italian Guidelines for the clinical practice established by Italian Society of Rheumatology
  4. Patients naive to anti-TNF drugs
  5. Outpatients

Exclusion Criteria:

Patients involved in controlled or interventional trials in the 12 previous months

Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesItaly
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00794118
Other Study ID Numbers0881A1-102321
B1801119
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2019

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

BY EMAIL

Contact

[email protected]

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