Clinical trial NCT01313858: A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)
Official title: Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 1613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Clinical Global Impression (CGI) Disease Status
timeFrame: Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24
measure: Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score
timeFrame: Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
timeFrame: Baseline and Months 3, 6, 12, 18, 24
measure: Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score
timeFrame: Baseline and Months 6, 12, 18, 24
measure: Number of Participants Who Experienced at Least One Adverse Event
timeFrame: Up to 24 months
measure: Number of Participants Who Experienced at Least One Serious Adverse Event
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kruger K, Burmester GR, Wassenberg S, Thomas MH. Golimumab as the First-, Second-, or at Least Third-Line Biologic Agent in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis: Post Hoc Analysis of a Noninterventional Study in Germany. Rheumatol Ther. 2020 Jun;7(2):371-382. doi: 10.1007/s40744-020-00204-9. Epub 2020 Apr 17.
citation: Kruger K, Burmester GR, Wassenberg S, Bohl-Buhler M, Thomas MH. Patient-reported outcomes with golimumab in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: non-interventional study GO-NICE in Germany. Rheumatol Int. 2019 Jan;39(1):131-140. doi: 10.1007/s00296-018-4180-4. Epub 2018 Nov 10.
citation: Kruger K, Burmester GR, Wassenberg S, Bohl-Buhler M, Thomas MH. Effectiveness and safety of golimumab in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis under real-life clinical conditions: non-interventional GO-NICE study in Germany. BMJ Open. 2018 Jun 14;8(6):e021082. doi: 10.1136/bmjopen-2017-021082.