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

This study is currently recruiting participants.
Verified April 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01313858
First received: March 10, 2011
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing
 Drug: Simponi®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study Investigating the Use of Simponi® in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Resource links provided by NLM:

Drug Information available for: Golimumab
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change in Clinical Global Impression (CGI) Disease Status [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impression (CGI) Disease Status [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impression (CGI) Disease Status [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impression (CGI) Disease Status [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impression (CGI) Disease Status [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impression (CGI) Disease Status [ Time Frame: Baseline and Month 18 ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impression (CGI) Disease Status [ Time Frame: Baseline and Month 21 ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impression (CGI) Disease Status [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in FFbH (Funktionsfragebogen Hannover) Questionnaire Score [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
  • Change in FFbH (Funktionsfragebogen Hannover)Questionnaire Score [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
  • Change in FFbH (Funktionsfragebogen Hannover) Questionnaire Score [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
  • Change in FFbH (Funktionsfragebogen Hannover) Questionnaire Score [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
  • Change in FFbH (Funktionsfragebogen Hannover) Questionnaire Score [ Time Frame: Baseline and Month 15 ] [ Designated as safety issue: No ]
  • Change in FFbH (Funktionsfragebogen Hannover) Score [ Time Frame: Baseline and Month 18 ] [ Designated as safety issue: No ]
  • Change in FFbH (Funktionsfragebogen Hannover) Questionnaire Score [ Time Frame: Baseline and Month 21 ] [ Designated as safety issue: No ]
  • Change in FFbH (Funktionsfragebogen Hannover) Questionnaire Score [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
  • Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
  • Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
  • Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
  • Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score [ Time Frame: Baseline and Month 18 ] [ Designated as safety issue: No ]
  • Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: April 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants with Rheumatoid Arthritis Drug: Simponi®
50 mg subcutaneous injection once monthly
Other Name: Golimumab
Participants with Psoriatic Arthritis Drug: Simponi®
50 mg subcutaneous injection once monthly
Other Name: Golimumab
Participants with Ankylosing Spondylitis Drug: Simponi®
50 mg subcutaneous injection once monthly
Other Name: Golimumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants in a primary care clinic or office with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis for whom the treatment with Simponi® by autoinjector device is to be initiated for the first time

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313858

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Germany
Merck Sharp & Dohme GmbH Recruiting
Haar, Germany
Contact: Kristian Lobner     49 89 4561 1102        
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01313858     History of Changes
Other Study ID Numbers: P06554
Study First Received: March 10, 2011
Last Updated: April 19, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
 Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Ankylosis

ClinicalTrials.gov processed this record on May 16, 2013