Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195377
First received: September 13, 2005
Last updated: June 17, 2009
Last verified: June 2009
  Purpose
The purpose of this study is to assess the safety of etanercept in patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) or psoriatic arthritis (PsA) in Spain

Condition Intervention Phase
Arthritis, Psoriatic
Arthritis, Rheumatoid
Drug: Etanercept
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter Study

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Estimated Enrollment: 1000
Study Start Date: April 2003
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with rheumatoid arthritis, psoriatic arthritis or AIJ, treated with etanercept in rheumatology units
Criteria

Inclusion Criteria:

  • RA or PsA in whom DMARDs/antiTNF antibodies/anti IL1 has been insufficient or inappropriate
  • Children from 4 to 17 years old with JIA polyarticular

Exclusion Criteria:

  • Clinically significant abnormal screening lab values
  • Patients who are planning to undergo elective surgery during the study period.
  • Other current autoimmune connective tissue diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195377

Locations
Spain
Madrid, Spain, 28007
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

ClinicalTrials.gov Identifier: NCT00195377     History of Changes
Other Study ID Numbers: 101393 
Study First Received: September 13, 2005
Last Updated: June 17, 2009
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Arthritis, Rheumatoid
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 25, 2016