None listed
Conditions
Interventions
Group A Type of group
Patients will receive 360 mg of MLTA3698A SC every 14 days for a total of six doses. It will consist of the medicine of! I study in two syringes (Syringe 1 and Syringe 2).
Group name:Group C Type of group
Patients will receive a placebo from MLTA3698A SC (Syringes 1 and 2) every 14 days for a total of six doses.
Sponsors
GENENTECH, INC.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of RA according to the 1987 revised ACR Criteria for the Classification of RA for at least 6 months prior to screening • Positive for rheumatoid factor or anti-cyclic citrullinated peptide (CCP) antibody, or both • Active disease, defined as: CRP >= 1.0 mg/dL; swollen joint count >= 6 (66 joint count); tender joint count >= 6 (68 joint count) • Previous inadequate clinical response to at least one disease-modifying anti-rheumatic drug (DMARD) consisting of either methotrexate (MTX) or leflunomide (LFU) • For patients currently receiving corticosteroids: Treatment at a stable dose during last 4 weeks prior to screening • For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening • For patients currently receiving sulfasalazine or anti-malarials: Treatment initiated and continued for at least the last 6 months prior to screening and on a stable dose • For patients of reproductive potential (males and females): Willing to use a highly effective birth control method for the duration of the study according to local guidelines
Exclusion criteria
Exclusion criteria: • Pregnant, planning to become pregnant during the study, or breastfeeding • Clinically significant abnormal laboratory values or abnormal ECG or vital signs • History of anaphylactic reactions • Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty´s syndrome), however patients with secondary Sjogren´s syndrome are eligible for the study • History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthritis, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, or other overlap syndrome) • Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C, tuberculosis • Administration of a live, attenuated vaccine within 1 month before dosing or anticipation that such a live attenuated vaccine will be required during the study • Previous treatment with anti-TNF biologics or other biologic agents, including anti-CD20-directed therapy (e.g. rituximab), anti-IL6-directed therapy (e.g. tocilizumab), or T cell-directed therapy (e.g. abatacept)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:DAS28 (4) -ESR is the disease activity rating in rheumatoid arthritis that takes into account four components, including the erythrocyte sedimentation rate (ESR), the painful joint count and the inflamed joint count of 28 joints, and the overall evaluation of! patient of disease activity. Measure:Change from baseline visit (Day 1) in DAS28 (4) -ESR rating on day 85. Timepoints:day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The response ACR20, ACR50, ACR70, and EULAR on Day 85 will be evaluated with the Mantel-Haenszel study classified by region and by the concomitant medication administered to patients during their participation in the study. Measure:Proportions of patients who obtained response criteria ACR20, ACR50, and ACR70 (see Annex D) on Day 85 Timepoints:Day 85 ; Outcome name:The response ACR20, ACR50, ACR70, and EULAR on Day 85 will be evaluated with the Mantel-Haenszel study classified by region and by the concomitant medication administered to patients during their participation in the study. Measure:Individual components of the ACR improvement criteria on Day 85, including inflamed joint count, doiorous joint count, ESR and GRP level, and VAS ratings Timepoints:Day 85 ; Outcome name:The results of HAQ-DI and SF-36, results VAS, CRP, change from baseline visit in CRP, ESR, change from baseline visit in ESR, DAS28 (4) -ESR, DAS28 (4) -CRP, joint count Swollen and painful joint counts on Day 85 will be evaluated using an ANOVA model with concomitant medication, region and treatment groups as terms of exploration in the model. Measure:DAS28 (4) -ESR rating and DAS28 (4) -CRP rating on Day 85 Timepoints:Day 85 ; Outcome name:The response ACR20, ACR50, ACR70, and EULAR on Day 85 will be evaluated with the Mantel-Haenszel study classified by region and by the concomitant medication administered to patients during their participation in the study. Measure:The European League response rate (EULAR) against rheumatism, according to the definition of a good to moderate response, on Day 85 Timepoints:Day 85 | — |
Countries
Bulgaria, Chile, Germany, Hungaria, Mexico, Peru, Poland, Romania, Spain, United States
Contacts
Public ContactAndres Cesar Martin Bayona
PPD Peru S.A.C.
Outcome results
None listed