Effect on secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (adalimumab biosimilar)

Phase 1

• Conditions: Ankylosing spondylitis; MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-000679-10-SK
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-02
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 837

Inclusion Criteria

- Male or non-pregnant, non-nursing female patients at least 18 years of age.
- Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/non biologic DMARD therapy.
- Active AS assessed by total BASDAI = 4 on a scale of 0-10.
- Spinal pain as measured by BASDAI question #2 = 4 (0-10).
- Total back pain as measured by visual analog scale (VAS) = 40 mm (0-100 mm).
- hsCRP = 5mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray.

Other protocol-defined inclusion criteria may apply,
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 753
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

Exclusion Criteria

- Patients with total ankylosis of the spine.
- Pregnant or nursing (lactating) women.
- Evidence of ongoing infectious or malignant process.
- Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFa.
- Subjects taking high potency opioid analgesics.
- Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents.

Other protocol-defined exclusion criteria may apply,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified