Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab

NCT ID: NCT03557853

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2021-06-30

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%.

Conditions

Ankylosing Spondylitis; Coxitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Golimumab injection

Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label.

Golimumab Injection

Intervention Type: DRUG

Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.

Interventions

Golimumab Injection

Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.

Intervention Type: DRUG

Other Intervention Names

Based on decision of investigators.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MSD Pharmaceuticals LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ekaterina Lukyanova, MD

Role: STUDY_DIRECTOR

MSD Pharmaceuticals LLC

Locations

KhMAO Regional Clinical Hospital

Khanty-Mansiysk, , Russia

Moscow Clinical Scientific Center

Moscow, , Russia

Pirogov National Medical Surgical Center

Moscow, , Russia

Rheumatology Research Institute

Moscow, , Russia

Regional Clinical Hospital #2

Rostov-on-Don, , Russia

City Clinical Hospital

Yakutsk, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MK-8259-021

Identifier Type: -

Identifier Source: org_study_id