Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00195689 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Last Update Posted : August 29, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Psoriatic Arthritis | Biological: Human anti-TNF monoclonal antibody/adalimumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 400 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | August 2003 |

- Safety parameters
- ACR 20/50/70
- PsARC
- HAQ
- SF-36
- FACTIT Fatigue Scale
- Disease progression measurements
- Patient reported outcomes
- Clinical response indicators

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject completed study M02-518 or M02-570
Exclusion Criteria:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195689
United States, Illinois | |
Global Medical Information-Abbott Laboratories | |
Abbott Park, Illinois, United States, 60064 |
Study Director: | Beverly Paperiello | Abbott |
ClinicalTrials.gov Identifier: | NCT00195689 |
Other Study ID Numbers: |
M02-537 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | August 29, 2007 |
Last Verified: | August 2007 |
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Psoriasis |
Skin Diseases, Papulosquamous Skin Diseases Adalimumab Antibodies Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |