Clinical trial NCT03557853: Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab
Official title: A Prospective Observational Study to Evaluate Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Simponi® (Golimumab)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Coxitis
Lead sponsor: MSD Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2018-06-15
Enrollment: 39
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: Patients with ankylosing spondylitis and coxitis followed in normal practice, in whom golimumab has been newly prescribed.

Brief summary: Rationale. Coxitis in AS is inflammation of hip(s) affecting significant number of patients. It is associated with worse function and more expressed axial disease requiring hip replacement at end-stage. Number of studies dedicated to coxitis treated with TNF alpha inhibitors is very limited.

Primary objective. To evaluate change of functional impairment in AS patients with coxitis from baseline to 12 months of therapy with golimumab by BASFI in daily clinical practice

Study design. This study is a non-interventional prospective observational cohort study conducted in multiple centers across Russia.

Study population. Patients with ankylosing spondylitis (according to the modified New York criteria) with coxitis newly prescribed golimumab during the course of usual clinical care will be enrolled and followed prospectively for 24 months with data collection at the approximate time points: baseline (pre-treatment) and consequent every 6 months. Patients will receive golimumab as prescribed in regular clinical practice.

Statistical Methods. Quantitative variables will be tested for normal distribution using the Shapiro-Wilk test. The hypothesis of equality of variances will be tested using Levene's test. Quantitative variables matching a normal distribution will be described in terms of the mean ± standard deviation, and values outside of the normal distribution as medians, 25% and 75% quartiles. Qualitative variables will be presented in the form of percentages of the absolute value N.

Sample Size and Power Calculations. Sample size calculation is based on data from GO-RAISE registration study in which golimumab was evaluated in patients with AS. The baseline BASFI was 5.0 which changed by mean (± SD, standard deviation) -2.5 (± 2.12) at week 52 (approximately 12 months). The analysis of the data shows that the minimum necessary sample size should be 18 patients to show a statistically significant change of BASFI from baseline to 12 months. On this basis and considering that the dropout rate over the two years is expected to be 30%, we decided that the necessary number of patients to be included into protocol should be 39 individuals. It is expected that around 27 patients will be included in the patient set completing the study. Power of the study is 90% with formula evaluation P = 1-β where P is power and β is type 2 error = 10%.


Eligibility criteria: Inclusion Criteria:

1. Adult patients (\>18 years of age) with definite AS (as per modified New York criteria)
2. Coxitis with BASRI-hip score 0-2
3. Newly prescribed golimumab according to usual clinical practice
4. Naïve to anti-TNFs or other biologic agents prior to initiation of golimumab as indicated by the patient's medical records
5. Patient is enrolled after the investigator's decision to treat with golimumab, but before initiation of treatment with golimumab
6. Patient was informed of the benefits and risks of golimumab as per normal practice using the product leaflet
7. Signed informed consent form

Exclusion Criteria:

1. Any contraindication to golimumab in accordance to the label of Simponi®
2. BASRI-hip score 3-4
3. Any contraindication to MRI, e.g. previous hip joint replacement, heart pace maker.

Primary outcomes:
measure: BASFI (Bath Ankylosing Spodylitis Functionality Index) at 12 Months of Follow-up
timeFrame: From baseline to 12 months
Secondary outcomes:
measure: BASFI (Bath Ankylosing Spodylitis Functionality Index) at 24 Months of Follow-up
timeFrame: From baseline to 24 months
measure: BASMI (Bath Ankylosing Spodylitis Mobility Index) at 12 Months of Follow-up
timeFrame: From baseline to 12 months
measure: BASMI (Bath Ankylosing Spodylitis Mobility Index) at 24 Months of Follow-up
timeFrame: From baseline to 24 months
measure: ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 12 Months of Follow-up
timeFrame: From baseline to 12 months
measure: ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 24 Months of Follow-up
timeFrame: From baseline to 24 months
measure: BASDAI (Bath AS Disease Activity Index) at 12 Months of Follow-up
timeFrame: From baseline to 12 months
measure: BASDAI (Bath AS Disease Activity Index) at 24 Months of Follow-up
timeFrame: From baseline to 24 months
measure: BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 12 Months of Follow-up
timeFrame: From baseline to 12 months
measure: BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 24 Months of Follow-up
timeFrame: From baseline to 24 months
Other outcomes:
measure: Percentage of Participants Without MRI Inflammatory Lesions in the Right Hip at 6 Months of Follow-up
timeFrame: 6 months from the baseline
measure: Percentage of Participants Without MRI Inflammatory Lesions in the Left Hip at 6 Months of Follow-up
timeFrame: 6 months from the baseline
measure: Percentage of Participants Without MRI Inflammatory Lesions in the Right Hip at 12 Months of Follow-up
timeFrame: 12 months from the baseline
measure: Percentage of Participants Without MRI Inflammatory Lesions in the Left Hip at 12 Months of Follow-up
timeFrame: 12 months from the baseline
measure: Percentage of Participants Without US Inflammatory Lesions in the Right Hip at 6 Months of Follow-up
timeFrame: 6 months from the baseline
measure: Percentage of Participants Without US Inflammatory Lesions in the Left Hip at 6 Months of Follow-up
timeFrame: 6 months from the baseline
measure: Percentage of Participants Without US Inflammatory Lesions in the Right Hip at 12 Months of Follow-up
timeFrame: 12 months from the baseline
measure: Percentage of Participants Without US Inflammatory Lesions in the Left Hip at 12 Months of Follow-up
timeFrame: 12 months from the baseline
Locations:
city: Khanty-Mansiysk
country: Russian Federation
facility: KhMAO Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center
city: Moscow
country: Russian Federation
facility: Pirogov National Medical Surgical Center
city: Moscow
country: Russian Federation
facility: Rheumatology Research Institute
city: Rostov-on-Don
country: Russian Federation
facility: Regional Clinical Hospital #2
city: Yakutsk
country: Russian Federation
facility: City Clinical Hospital
Study officials:
affiliation: MSD Pharmaceuticals LLC
name: Ekaterina Lukyanova, MD
role: STUDY_DIRECTOR
References: