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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01313858
First received: March 10, 2011
Last updated: September 12, 2016
Last verified: September 2016
  Purpose
This is a study to assess the use of golimumab (Simponi®) in participants with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The study objective is to evaluate the clinical safety of golimumab (Simponi®) under real-life, clinical practice conditions as assessed by the incidence and type of (serious) adverse events and changes in clinical status of participants as assessed by clinical parameters.

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

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Clinical Global Impression (CGI) Disease Status [ Time Frame: Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24 ] [ Designated as safety issue: No ]
    The CGI is a non-disease-specific evaluation of participants' overall health status assessed on a 10 mm visual analogue scale (VAS) ranging from "0" (free of complaints) to "10" (strong discomfort). The closer the score to 0, the better the health status.

  • Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score [ Time Frame: Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24 ] [ Designated as safety issue: No ]
    The FFbH is a participant questionnaire assessing disability/functional impairment. Ability to perform 18 activities of daily living are scored on a 3 point scale (2=Yes, 1=Yes but with effort, and 0=No or with assistance) and summed. Remaining functional capacity is calculated as the percent of the maximum number of score points (FFbH[%] = (Attained score*100)/(2*n) where n is the number of completed responses) with range from 0 = total loss of functional capacity to 100 = maximal functional capacity. Increase from baseline in FFbH score signifies improvement. The FFbH is similar to Health Assessment Questionnaire (HAQ) but is more widely used in Germany.

  • Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score [ Time Frame: Baseline and Months 3, 6, 12, 18, 24 ] [ Designated as safety issue: No ]
    The FACIT-F scale assesses self-reported fatigue and its impact upon daily activities and function. 13 items consisting of fatigue, weakness, listlessness, tiredness, trouble with starting things, trouble with finishing things, energy, activity, sleep, eating, help doing activities, frustration, and social activities are scored on a scale of 0 (not at all) to 4 (very much), except energy and activity which are reversed scored. Individual item scores are then summed to provide the final FACIT-F score with range from 0 (lowest) to 52 (highest quality of life). Increase from baseline in FACIT-F score signifies improvement.

  • Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score [ Time Frame: Baseline and Months 6, 12, 18, 24 ] [ Designated as safety issue: No ]
    The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. Decrease from baseline in EQ-5D-3L signifies improvement.

  • Number of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
    An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

  • Number of Participants Who Experienced at Least One Serious Adverse Event [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
    A serious adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure that results in death, life-threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.


Enrollment: 1613
Study Start Date: April 2010
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants with Rheumatoid Arthritis
Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
Drug: Simponi®
Other Name: Golimumab
Drug: Methotrexate
Given concomitantly with Simponi®
Participants with Psoriatic Arthritis
Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
Drug: Simponi®
Other Name: Golimumab
Participants with Ankylosing Spondylitis
Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
Drug: Simponi®
Other Name: Golimumab

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01313858     History of Changes
Other Study ID Numbers: P06554  MK-8259-005 
Study First Received: March 10, 2011
Results First Received: September 12, 2016
Last Updated: September 12, 2016
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Antibodies, Monoclonal
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016