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

NCT03557853 | Completed Results FDA Drug

• 1 other identifier: MK-8259-021
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• BASFI (Bath Ankylosing Spodylitis Functionality Index) at 12 Months of Follow-up

  The BASFI is a self-assessment instrument for defining functional ability in patients with AS. Contains 10 items: 8 items concerning activities referring to the functional anatomy of the patients (bending, reaching, changing position, standing, turning, and climbing steps) and 2 items assessing the patients' ability to cope with everyday life. Consists of Numeric response scale (0-10) from "easy" to "impossible." The mean of the 10 individual scales (scores) gives the BASFI score - a value between 0 and 10 with 0 reflecting no functional impairments and 10 reflecting maximal impairment.

  From baseline to 12 months

Secondary Outcomes (9)

• BASFI (Bath Ankylosing Spodylitis Functionality Index) at 24 Months of Follow-up

  From baseline to 24 months

• BASMI (Bath Ankylosing Spodylitis Mobility Index) at 12 Months of Follow-up

  From baseline to 12 months

• BASMI (Bath Ankylosing Spodylitis Mobility Index) at 24 Months of Follow-up

  From baseline to 24 months

• ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 12 Months of Follow-up

  From baseline to 12 months

• ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 24 Months of Follow-up

  From baseline to 24 months

Other Outcomes (8)

• Percentage of Participants Without MRI Inflammatory Lesions in the Right Hip at 6 Months of Follow-up

  6 months from the baseline

• Percentage of Participants Without MRI Inflammatory Lesions in the Left Hip at 6 Months of Follow-up

  6 months from the baseline

• Percentage of Participants Without MRI Inflammatory Lesions in the Right Hip at 12 Months of Follow-up

  12 months from the baseline

Study Arms (1)

Golimumab injection

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

Drug: Golimumab Injection

Interventions

Golimumab Injection DRUG

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

Also known as: Based on decision of investigators.

Golimumab injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ankylosing spondylitis and coxitis followed in normal practice, in whom golimumab has been newly prescribed.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MSD Pharmaceuticals LLC: lead

Study Sites (6)

KhMAO Regional Clinical Hospital

Khanty-Mansiysk, Russia

Location

Moscow Clinical Scientific Center

Moscow, Russia

Location

Pirogov National Medical Surgical Center

Moscow, Russia

Location

Rheumatology Research Institute

Moscow, Russia

Location

Regional Clinical Hospital #2

Rostov-on-Don, Russia

Location

City Clinical Hospital

Yakutsk, Russia

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

golimumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Results Point of Contact

• Title: Vladimir Achikyan
• Organization: MSD Pharmaceuticals LLC

vladimir.achikyan@merck.com

+74959167100

Study Officials

• Ekaterina Lukyanova, MD

  MSD Pharmaceuticals LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: June 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: June 30, 2021
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-03

Locations

RU (6)