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Health Condition(s) or Problem
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Rheumatoid Arthritis
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Lay Summary
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This study will assess the safety and efficacy of secukinumab when added to a background
therapy in patients with active rheumatoid arthritis (RA) who are intolerant to or have had
an inadequate response to anti-tumor necrosis factor (TNF)-a agents.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion criteria:
- Male or non-pregnant, non-lactating female patients
- Presence of RA classified by American College of Rheumatology (ACR) 2010 revised
criteria for at least 3 months before screening
- At Baseline: Disease activity criteria defined by = 6 tender joints out of 68 and =6
swollen joints out of 66 with at least 1 of the following at screening:
- Anti-Cyclic Citrullinated Peptide (CCP) antibodies positive OR
Rheumatoid Factor positive and with at least 1 of the following at screening:
- High sensitivity C-reactive protein (hsCRP) = 10 mg/L OR Erythrocyte sedimentation
rate (ESR) = 28 mm/1st hr
- Patients must have been taking at least one anti-TNF-a agent given at an approved
dose for at least 3 months before randomization and have experienced an inadequate
response to treatment or have been intolerant to at least one administration of an
anti-TNF-a agent
- Patients must be taking MTX for at least 3 months before randomization and have to be
on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week For Japan
only: 6 to 25 mg/week)
Exclusion criteria:
- Chest x-ray with evidence of ongoing infectious or malignant process, obtained within
3 months prior to screening and evaluated by a qualified physician RA patients
functional status class IV according to the ACR 1991 revised criteria
- Patients who have ever received biologic immunomodulating agents except for those
targeting TNFa
- Previous treatment with any cell-depleting therapies including but not limited to
anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3,
anti-CD19)
- Other protocol-defined inclusion/exclusion criteria may apply.
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Who cannot enter the trial
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Inclusion criteria:
- Male or non-pregnant, non-lactating female patients
- Presence of RA classified by American College of Rheumatology (ACR) 2010 revised
criteria for at least 3 months before screening
- At Baseline: Disease activity criteria defined by = 6 tender joints out of 68 and =6
swollen joints out of 66 with at least 1 of the following at screening:
- Anti-Cyclic Citrullinated Peptide (CCP) antibodies positive OR
Rheumatoid Factor positive and with at least 1 of the following at screening:
- High sensitivity C-reactive protein (hsCRP) = 10 mg/L OR Erythrocyte sedimentation
rate (ESR) = 28 mm/1st hr
- Patients must have been taking at least one anti-TNF-a agent given at an approved
dose for at least 3 months before randomization and have experienced an inadequate
response to treatment or have been intolerant to at least one administration of an
anti-TNF-a agent
- Patients must be taking MTX for at least 3 months before randomization and have to be
on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week For Japan
only: 6 to 25 mg/week)
Exclusion criteria:
- Chest x-ray with evidence of ongoing infectious or malignant process, obtained within
3 months prior to screening and evaluated by a qualified physician RA patients
functional status class IV according to the ACR 1991 revised criteria
- Patients who have ever received biologic immunomodulating agents except for those
targeting TNFa
- Previous treatment with any cell-depleting therapies including but not limited to
anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3,
anti-CD19)
- Other protocol-defined inclusion/exclusion criteria may apply.
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What will happen
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Drug; Secukinumab (75 mg); Biological; Group 1; Drug; Secukinumab (150 mg); Biological; Group 2; Drug; Placebo; Biological; Group 3
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Primary aim
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efficacy (proportion of patients achieving an ACR20 response) at 75 mg or 150 mg of secukinumab (AIN457) compared to placebo as add-on therapy in patients with active RA despite stable treatment with methotrexate (MTX)
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Secondary Aim
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improvement (change) of the Health Assessment Questionnaire - Disability Index (HAQ-DI) from baseline on secukinumab 75 mg or 150 mg compared to placebo; Week 24; No; change of the van der Heijde total modified Sharp score on secukinumab 75 mg or 150 mg or both secukinumab doses is superior to placebo; Week 24; No; proportion of patients achieving major clinical response (continuous six-month period of ACR70 response) on secukinumab 75 mg or 150 mg compared to placebo (as originally randomized); 1 Year; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Cannock, London, Newcastle upon Tyne
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