Rheumatoid arthritis
Conditions
Interventions
investigational material(s)
Generic name etc : Sirukumab
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigat
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - Completed participation in Studies CNTO136ARA3002 or CNTO136ARA3003 - Signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study - Signed an informed consent form (ICF) for pharmacogenetics research (how a person's genes may affect a drug's effects) in order to participate in the optional pharmacogenetics component of this study. Refusal to give consent for this component does not exclude a participant from participation in this clinical study
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or CNTO136ARA3003 - Is pregnant - Has active diverticulitis - Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of participants with cardiovascular serious adverse events (SAEs), malignancies, serious infections, gastrointestinal perforations up to 224 weeks The number of participants with cardiovascular serious adverse events (SAEs), malignancies, serious infections, gastrointestinal perforations up to 224 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Observations of laboratory parameters of interest (neutrophils, platelets, hepatobiliary parameters, and lipid parameters) - Up to 224 weeks Proportion of participants who achieve ACR 20 response / 50 response / 70 response Proportion of participants with DAS28 (CRP) response / DAS28 (CRP) remission Change from baseline in DAS28 (CRP) Proportion of participants with SDAI-based ACR/EULAR remission Proportion of participants with Boolean-based ACR/EULAR remission Change from baseline in SDAI Change from baseline in HAQ-DI Proportion of HAQ-DI responders (ie, those who have a change from baseline of > 0.22 in HAQ-DI score) Change from baseline in Physial Component Score (PCS) / in Mental Component Score (MCS) /in domain scores of 36-item short form health survey (SF-36) | — |
Outcome results
None listed