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OpenTrials
Completed

NCT Number: NCT00195689

Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis

The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Global Medical Information-Abbott Laboratories

Abbott Park, Illinois, 60064, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject completed study M02-518 or M02-570

Exclusion criteria

  • Subject prematurely discontinued study M02-518 or M02-570
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study

Treatment and study plan

Human anti-TNF monoclonal antibody/adalimumab

Biological

Primary outcomes

  1. Safety parameters

  2. ACR 20/50/70

  3. PsARC

  4. HAQ

  5. SF-36

  6. FACTIT Fatigue Scale

  7. Disease progression measurements

Secondary outcomes

  1. Patient reported outcomes

  2. Clinical response indicators

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Moderate to Severely Active Psoriatic Arthritis

Important dates

Study start
2003
First posted
Sep 20, 2005
Registry last updated
Aug 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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