Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists

• ClinicalTrials.gov Identifier: NCT00293722
• Recruitment Status: Completed
• First Posted: February 17, 2006
• Results First Posted: February 26, 2014
• Last Update Posted: February 26, 2014
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

The purpose of this study is to evaluate the safety and effectiveness of etanercept under usual care settings in patients with PsA treated by rheumatologists.

Condition or disease	Intervention/treatment
Arthritis, Psoriatic; Psoriasis; Skin Diseases, Papulosquamous	Drug: Etanercept

Detailed Description:

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Study Design

• Study Type: Observational
• Actual Enrollment: 1308 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Post Marketing Surveillance to Evaluate the Safety and Efficacy of Etanercept Under Usual Care Settings in Patients With Psoriatic Arthritis (PsA) Treated by Rheumatologists
• Study Start Date: January 2006
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: February 2013

Groups and Cohorts

Group/Cohort	Intervention/treatment
Patients with Psoriatic Arthritis	Drug: Etanercept; The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 52 ]
   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.

Secondary Outcome Measures :

1. Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 [ Time Frame: Baseline, Week 52 ]
2. Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 [ Time Frame: Baseline, Week 52 ]
   DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity.
3. Change From Baseline in Ritchie Index at Week 52 [ Time Frame: Baseline, Week 52 ]
   Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant's reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.
4. Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 [ Time Frame: Baseline, Week 52 ]
   Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.
5. Number of Participants With Nail Involvement [ Time Frame: Baseline, Week 12, 52 ]
   Number of participants with psoriatic arthritis affecting the nails are reported.
6. Change From Baseline in C-reactive Protein (CRP) at Week 52 [ Time Frame: Baseline, Week 52 ]
   The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
7. Change From Baseline in Patient Assessment of Itching at Week 52 [ Time Frame: Baseline, Week 52 ]
   Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.
8. Change From Baseline in Patient Assessment of Pain at Week 52 [ Time Frame: Baseline, Week 52 ]
   Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.
9. Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 [ Time Frame: Baseline, Week 52 ]
   SF-12 questionnaire was used to determine participants' quality of life (QoL). It comprised 12 items which covered 8 concepts: physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.

Other Outcome Measures:

1. Change From Baseline in Patient Global Assessment of Disease Activity at Week 52 [ Time Frame: Baseline, Week 52 ]
   Measured using a 100 mm visual analog scale (VAS) ranging from 0 mm = very good to 100 mm = very bad.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Psoriatic Arthritis

Criteria

Inclusion Criteria:

• Clinical diagnosis of psoriatic arthritis

Exclusion Criteria:

• Sepsis or risk for sepsis,
• Acute infection,
• Hypersensitivity against Etanercept

Contacts and Locations

Locations

Germany

Pfizer Investigational Site

Toerwang-Samerberg, Germany, 83122

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Behrens F, Meier L, Prinz JC, Jobst J, Lippe R, Loschmann PA, Lorenz HM. Simultaneous Response in Several Domains in Patients with Psoriatic Disease Treated with Etanercept as Monotherapy or in Combination with Conventional Synthetic Disease-modifying Antirheumatic Drugs. J Rheumatol. 2018 Jun;45(6):802-810. doi: 10.3899/jrheum.170932. Epub 2018 Apr 1.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00293722
• Other Study ID Numbers: 0881A6-102064; B1801127
• First Posted: February 17, 2006
• Results First Posted: February 26, 2014
• Last Update Posted: February 26, 2014
• Last Verified: January 2014

Keywords provided by Pfizer:

Arthritis

Additional relevant MeSH terms:

Arthritis; Arthritis, Psoriatic; Psoriasis; Skin Diseases; Skin Diseases, Papulosquamous; Joint Diseases; Musculoskeletal Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone 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