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AScalate: Treat-to-target in Axial Spondyloarthritis

NCT03906136 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2025-04-29

Study results available
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Summary

This was a randomized, parallel-group, open-label, multicenter study in patients with active axSpA. The aim of the study was to demonstrate that the efficacy of a T2T approach (with secukinumab as a first-line biologic) was superior to a SOC approach in terms of achieving strong clinical efficacy in patients with active axSpA who were naïve to biological therapy and who had an inadequate response to prior non-steroidal anti-inflammatory drug (NSAID) treatment.

Conditions

  • Axial Spondyloarthritis

Interventions

BIOLOGICAL

Secukinumab/Adalimumab-Biosimilar

Secukinumab 150 mg, s.c. Secukinumab 300 mg, s.c. Adalimumab biosimilar 40 mg, s.c.

OTHER

Standard-of-care

Treatment according to local practice standards by the rheumatologist following latest treatment recommendations with NSAIDs as the first-choice drug treatment and DMARDs for patients with active disease despite the use (or intolerance/contraindication) of NSAIDs.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-04
Primary Completion
2022-02-04
Completion
2022-09-22

Countries

  • France
  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03906136 on ClinicalTrials.gov