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Trial record 1 of 1 for:    NCT00293722
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Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists

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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:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 15, 2006
First Posted Date February 17, 2006
Results First Submitted Date January 10, 2014
Results First Posted Date February 26, 2014
Last Update Posted Date February 26, 2014
Study Start Date January 2006
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 10, 2014)
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00293722 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 10, 2014)
  • Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 [ Time Frame: Baseline, Week 52 ]
  • 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.
  • 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.
  • 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.
  • Number of Participants With Nail Involvement [ Time Frame: Baseline, Week 12, 52 ]
    Number of participants with psoriatic arthritis affecting the nails are reported.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 10, 2014)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists
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
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.
Detailed Description Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Arthritis, Psoriatic
  • Psoriasis
  • Skin Diseases, Papulosquamous
Intervention 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.
Study Groups/Cohorts Patients with Psoriatic Arthritis
Intervention: Drug: Etanercept
Publications * Behrens F, Meier L, Prinz JC, Jobst J, Lippe R, Löschmann 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 30, 2013)
1308
Original Enrollment
 (submitted: February 15, 2006)
500
Actual Study Completion Date February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of psoriatic arthritis

Exclusion Criteria:

  • Sepsis or risk for sepsis,
  • Acute infection,
  • Hypersensitivity against Etanercept
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00293722
Other Study ID Numbers 0881A6-102064
B1801127
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2014