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NCT01313858 Clinical Trial

A Study to Investigate the Use of Simponi® in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)

Arthritis, Rheumatoid Clinical Trial

— GO-NICE  

Official title:
Non-Interventional Study Investigating the Use of Simponi® in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01313858
Other study ID # P06554
Secondary ID
Status Completed
Phase N/A
First received March 10, 2011
Last updated October 25, 2015
Start date April 2010
Est. completion date September 2015

Study information
Verified date October 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Observational

Clinical Trial Summary

This is a study to assess the use of Simponi® in participants with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Recruitment information / eligibility
Status Completed
Enrollment 1521
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Has rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis and treatment with Simponi® by autoinjector device is to be initiated for the first time

Exclusion Criteria:

- No specific exclusion criteria

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Simponi®
50 mg subcutaneous injection once monthly

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Clinical Global Impression (CGI) Disease Status Baseline and Month 3 No
Primary Change in Clinical Global Impression (CGI) Disease Status Baseline and Month 6 No
Primary Change in Clinical Global Impression (CGI) Disease Status Baseline and Month 9 No
Primary Change in Clinical Global Impression (CGI) Disease Status Baseline and Month 12 No
Primary Change in Clinical Global Impression (CGI) Disease Status Baseline and Month 15 No
Primary Change in Clinical Global Impression (CGI) Disease Status Baseline and Month 18 No
Primary Change in Clinical Global Impression (CGI) Disease Status Baseline and Month 21 No
Primary Change in Clinical Global Impression (CGI) Disease Status Baseline and Month 24 No
Secondary Change in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Baseline and Month 3 No
Secondary Change in FFbH (Funktionsfragebogen Hannover)Questionnaire Score Baseline and Month 6 No
Secondary Change in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Baseline and Month 9 No
Secondary Change in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Baseline and Month 12 No
Secondary Change in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Baseline and Month 15 No
Secondary Change in FFbH (Funktionsfragebogen Hannover) Score Baseline and Month 18 No
Secondary Change in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Baseline and Month 21 No
Secondary Change in FFbH (Funktionsfragebogen Hannover) Questionnaire Score Baseline and Month 24 No
Secondary Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score Baseline and Month 3 No
Secondary Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score Baseline and Month 6 No
Secondary Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score Baseline and Month 12 No
Secondary Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score Baseline and Month 18 No
Secondary Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score Baseline and Month 24 No
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