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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
History of Changes
  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:

Drug Information available for: Etanercept
U.S. FDA Resources

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
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
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

No publications provided

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, Psoriatic
Arthritis, Rheumatoid
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013