A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis

A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001220-38-GB

Enrollment

350

Registered

2011-05-17

Start date

2011-07-12

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Powder for solution for injection or infusion INN or Proposed INN: Secukinumab Current Sponsor code: AIN457 Concentration unit: mg m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diagnosis of rheumatoid arthritis - Patients must be either DMARD naive or have failed at least one DMARD agent (e.g. MTX, leflunamide or sulfasalazine) - Patients are allowed up to 3 DMARDs at study entry (e.g. MTX, sulfasalazine or hydroxychloroquine) as long as their dose was stable for 4 weeks prior to initiating study treatment - Disease activity at screening defined by =6 out of 28 tender joints and =6 out of 28 swollen joints and hsCRP > 10mg/L Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 375 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 125

Exclusion criteria

Exclusion criteria: - Patients with severe rheumatoid arthritis (functional status class IV according to the ACR 1991 revised criteria) - Previous exposure to secukinumab or any other biologic, including TNF inhibitors - Use of high potency opioid analgesics - Pregnant or nursing (lactating) women - Use of any investigational drug other than rheumatoid arthritis therapy and/or devices at the time of randomization or within 30 days or 5 half-lives of randomization, whichever is longer. Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess if the treatment effect of Secukinumab in patients with Rheumatoid Arthritis after 12 weeks treatment is associated with a certain genetic disposition;Secondary Objective: To assess if the treatment effect of Secukinumab in patients with Rheumatoid Arthritis is associated with any other blood markers and to further assess the safety and tolerability of this drug;Primary end point(s): Evaluation of clinical response according to validated methods DAS (disease activity index) and ACR (American College of Rheumatology), with regards to a 20% improvement compared to baseline;Timepoint(s) of evaluation of this end point: 12 weeks assessment of ACR and DAS	—

Measure

Time frame

Main Objective: To assess if the treatment effect of Secukinumab in patients with Rheumatoid Arthritis after 12 weeks treatment is associated with a certain genetic disposition;Secondary Objective: To assess if the treatment effect of Secukinumab in patients with Rheumatoid Arthritis is associated with any other blood markers and to further assess the safety and tolerability of this drug;Primary end point(s): Evaluation of clinical response according to validated methods DAS (disease activity index) and ACR (American College of Rheumatology), with regards to a 20% improvement compared to baseline;Timepoint(s) of evaluation of this end point: 12 weeks assessment of ACR and DAS

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Secondary

Measure	Time frame
Secondary end point(s): Evaluation of clinical response according to a validated methods DAS (disease activity index) and ACR (American College of Rheumatology), with regards to a 50% resp. 70% improvement compared to baseline. Assessing the safety and tolerability of secukinumab;Timepoint(s) of evaluation of this end point: Assessment performed at each dosing visit with main focus of 12 weeks timepoint and end of study	—

Measure

Time frame

Secondary end point(s): Evaluation of clinical response according to a validated methods DAS (disease activity index) and ACR (American College of Rheumatology), with regards to a 50% resp. 70% improvement compared to baseline. Assessing the safety and tolerability of secukinumab;Timepoint(s) of evaluation of this end point: Assessment performed at each dosing visit with main focus of 12 weeks timepoint and end of study

—

Countries

Belgium, Germany, Russian Federation, United Kingdom, United States

Contacts

Public ContactMedical Information Services

Novartis Pharmaceuticals UK Ltd

medinfo.uk@novartis.com+4401276698370

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026