None listed
Conditions
Interventions
Group 1 Type of group
R935788 100 mg tablet, orally, twice-a-day for 3 months
Group name:Group 2 Type of group
Placebo, orally, twice-a-day for 3 months
Sponsors
Rigel Pharmaceuticals, Inc.,
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: • Patients must provide written informed consent by signing an Informed Consent Form (FCI) approved by a CRI / CE before being admitted to this study. • Men and women, 18 years of age or older, with active RA for at least 12 months prior to administration on Day 1 (functional class I-III, eg, not limited to bed or chair of wheels) Active AR is defined as the presence of (a)> 6 inflamed joints (28 joint count); AND (b)> 6 sensitive joints (28 joint count) AND at least one of the following (c) YSG> 28 mm / h or POR> LNS for the reference core laboratory. • Patients are currently receiving or previously received a biological treatment with a TNF inhibitor, rituximab, abatacept or anakinra at an approved dose for> 3 months prior to administration on Day 1 and were designated as failure to biological treatment due to lack of efficacy, safety or tolerability. • Patients can receive stable doses of methotrexate (MTX), azathioprine (not in combination with MTX), leflunomide (not in combination with MTX), sulfasalazine, chloroquine, hydroxychloroquine, gold, NSAIDs (including C0X2 inhibitors), minocycline or doxycycline The dose must have been stable for at least 30 days prior to administration on Day 1 and should not be modified during the wash, selection and treatment periods, unless indicated by the tolerability requirements. Patients taking MTX should have received weekly doses of MTX (7.5-25 mg / week) for a minimum of 3 months prior to administration on Day 1 and should be receiving a stable dose of MTX, without changes in the route, during the 6 weeks prior to administration on Day 1. Patients receiving MTX should also be receiving folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to administration on Day 1. • Women of childbearing age should be fully informed about the potential of R788 to adversely affect the fetus and, if they are sexually active, they should agree to use a well-established method of contraception during the study (oral contraceptives, mechanical barrier, long-acting hormonal agent) ). These patients should not be lactating and should have a negative urine pregnancy test at the time of randomization and at each laboratory determination. • The patient must be otherwise in good health condition, which will be determined by the Investigator based on a clinical history, physical examination and selection laboratory tests during the selection period. See the exclusion criteria for specific exclusions. • In the opinion of the Researcher, the patient has the capacity to understand the nature of! study and any danger that represents their participation, and to communicate satisfactorily with the Researcher and to participate in, and comply with, the requirements of the complete protocol.
Exclusion criteria
Exclusion criteria: 1) The patient has a history of, or currently suffers from, a significant disease, medium condition (in addition to arthritis) or laboratory abnormality that, in the opinion of the Investigator, could affect the conduct of the study. Specifically, patients who suffer the following are excluded; a) poorly controlled or uncontrolled hypertension; b) another autoinumne disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritic syndromes (gout, Lyme disease, Reiter´s syndrome); c) surgery or recent serious infectious disease (in the 2 months prior to administration on Day 1); d) recent history (the 5 years prior to administration on Day 1) of, or treatment for, a malignancy except nonmelanomatous skin cancer, or any history of.lilyfoma; e) positive Hepatitis B surface antigen; f) antibody to positive Hepatitis C; it can be included if the recombinant immunoblot analysis (RIBA) of Hepatitis C is negative, or if the HCV RNA is negative (qualitative); g) interstitial pneumonitis or active lung infection on chest x-ray (taken one month prior to selection); h) Tuberculosis (TB): the skin test for TB should be negative (if the patient never received vaccination, or if he was vaccinated more than 10 years ago, in this context, negative means induration 1.2x LNS, creatinine> 1.5x LNS, ANC <2,500 / mm ^ or lymphocyte count <600 / mm3, Hb <9 g are excluded / dL, platelet count <125,000 / mm3. 2) The patient has a history of substance abuse, drug addiction or alcoholism. Patients can consume up to 4 units of alcohol per week; however, alcohol consumption should be avoided during the 72 hours prior to laboratory evaluations. Patients who can not reliably comply with this requirement should be excluded. One unit of alcohol is defined as: Beer = 12 oz or 355 mL; wine = 5 oz or 148 mL; sweet table wine = 3 oz or 89 mL; distilled beverages with 80 alcohol = 1.5 oz or 44 mL. 3) The patient has been previously treated with R788 in a different protocol. 4) The patient has a pacemaker, aneurysm clips or other contraindication for an MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physicians assessment of disease activity, patients assessment of disease activity, patients assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP or ESR, after 3 months Measure:American College of Rheumatology 20 (ACR20) Timepoints:3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physicians assessment of disease activity, patients assessment of disease activity, patients assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months Measure:American College of Rheumatology 50 (ACR50) Response at 3 Months Timepoints:3 months ; Outcome name:The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physicians assessment of disease activity, patients assessment of disease activity, patients assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months Measure:American College of Rheumatology 70 (ACR70) Response at 3 Months Timepoints:3 months ; Outcome name:The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment Measure:American College of Rheumatology Index of Improvement (ACRn) at 3 Months Timepoints:3 months ; Outcome name:Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patients assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms Measure:Disease Activity Score-C-Reactive Protein (DAS28-CRP) 1.5x, >1.5-2x, >2-3x, >3x, >3-5x, >5-10x, >10x Upper Limit of Normal (ULN) Timepoints:Any time between baseline and 3 months ; Outcome name:The number of participants with AST (a test of liver function) values greater than 1.5, 1.5 to 2 times, 2 to 3 times, 3 times, 3 to 5 times, 5 to 10 times, 10 times times the ULN Measure:Aspartate Aminotransferase (AS | — |
Countries
Belgium, Brazil, Colombia, France, Germany, Italy, Peru, United States
Contacts
Public ContactGladys Aliaga
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed