Active Rheumatoid Arthritis MedDRA version: 23.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Code: AMT-101
Pharmaceutical Form: Gastro-resistant tablet
Current Sponsor code: AMT-101
Other descriptive name: AMT-101
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Applied Molecular Transport Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female and male patients aged =18 and 4.4 and = 5.1 or b) DAS28(CRP) = 3.2 and = 5.1 plus at least 2/28 swollen and tender joints (except joint surgery). • History of biologics treatment should be limited to anti-TNF agents among adalimumab, infliximab, golimumab, etanercept, certolizumab (including biosimilars). • Two or more swollen and tender joints in the Screening Phase (out of 28 joints). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: • Any history or complication of an inflammatory arthritic disorder other than RA • Any history of Inflammatory Bowel Disease (Ulcerative Colitis or Crohn’s disease) • Meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class IV. • Received IV Immunoglobulin (IV Ig) preparations or blood products within 24 weeks before starting the study treatment. • Received a live vaccine within 12 weeks before starting the study treatment, or is planning to receive a live vaccine during the study • Current therapy with any non-MTX synthetic small-molecule DMARD (including but not limited to sulfasalazine, azathioprine, hydroxychloroquine, and/or leflunomide) for at least 1 month prior to the Screening Visit or concomitantly during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 12 weeks;Main Objective: To assess the safety and tolerability of 12 weeks of daily oral AMT-101 in patients with active RA who have an inadequate response to anti-TNF therapy;Secondary Objective: • To assess the biologic activity of 12 weeks of daily oral AMT-101 by changes in the DAS-28 (CRP), SDAI and CDAI, and ACR 20, 50, 70 • To examine the pharmacokinetic and pharmacodynamic effects of AMT-101 • To examine the immunogenicity of AMT-101 ;Primary end point(s): • Proportion of patients with treatment-emergent adverse events (TEAEs), SAEs, and discontinuation due to TEAEs • Assessment of physical examinations, laboratory parameters, vital signs, and ECGs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Efficacy: Change over time in: - DAS-28(CRP), SDAI and CDAI, ACR 20, 50,70 - Proportion of patients with DAS-28(CRP) less than 2.6 - Proportion of patients with DAS-28(CRP) less than 3.2 - Proportion of patients with Boolean Remission - Change in acute phase reactants (CRP, ESR) • Pharmacokinetics: Change in AMT-101 and Serum IL-10 levels • Pharmacodynamics: Change in Rheumatoid Factor, anti-citrullinated Cyclic Peptide antibody levels • Immunogenicity: Incidence of anti-AMT-101 antibodies ;Timepoint(s) of evaluation of this end point: • Efficacy: at treatment completion and 4 weeks post completion • Pharmacokinetics: baseline, Day 1- at 8 and 24 hrs. and at weeks 2, 4, 8, and 12 • Pharmacodynamics: baseline and at week 12 and 16 • Immunogenicity: baseline and weeks 12 and 16 | — |
Countries
Germany
Contacts
Public ContactClincial Trial AMT-101-204
Applied Molecular Transport Inc.
Outcome results
None listed