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

NCT00794118

Last updated date
Study Location
Pfizer Investigational Site
Roma, , 00161, Italy
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)
Official Title Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study
Brief Summary The 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 Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population primary care clinic
Condition Rheumatoid Arthritis
Intervention Other: As per clinical practice
As per clinical practice
Other Name: Observational study
Study Groups/Cohorts 1.0
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 Status Completed
Actual Enrollment
 (submitted: June 28, 2011)
299
Original Estimated Enrollment
 (submitted: November 18, 2008)
500
Actual Study Completion Date April 2011
Actual Primary Completion Date April 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
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT00794118
Other Study ID Numbers 0881A1-102321
B1801119
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2019