Rheumatoid Arthritis
Conditions
Brief summary
The study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks daily treatment with 100 mg AP1189 in RA patients who are to start up-titration with methotrexate (MTX).
Interventions
DRUG100 mg AP1189
AP1189 tablets for oral use
DRUGPlacebo
Matching placebo for oral use
Sponsors
NBCD A/S
SynAct Pharma Aps
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Multi-center, randomized, double-blind, placebo-controlled study with 12 weeks of treatment with AP1189 or placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Confirmed diagnosis of RA according to the 2010 ACR/EULAR RA classification criteria and are ACR class I-III * ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts). * Candidate for MTX treatment * Is about to begin treatment with MTX * Must meet at least one of the following parameters at Screening: 1. positive result for anti-CCP or RF 2. Serum CRP ≥ 6 mg/L * Highly active RA (CDAI \> 22) at screening and baseline * Negative QuantiFERON-in-Tube test (QFG-IT) * Females of child-bearing potential must use of highly effective birth control method Main
Exclusion criteria
* Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within 1 month following randomization * Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA. Sjögren's syndrome with RA is allowable * Prior history of or current inflammatory joint disease other than RA * Subjects with fibromyalgia * Use of hydroxychloroquine within 4 weeks prior the Screening Visit * Initiation of, or change in existing NSAID treatment within 2 weeks prior to the baseline visit * Corticosteroids except inhaled or nasal formulations for seasonal allergy or asthma are prohibited within 2 weeks prior to screening * Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease * Have prior renal transplant, current renal dialysis, or severe renal insufficiency * Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids * Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured) * Neuropathies or other painful conditions that might interfere with pain evaluation * Body weight of \>150 kg * HBsAg positive and/or Anti-HBc with sign of current infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of reported AEs | 12 weeks | Evaluation of the safety and tolerability of AP1189 on the number and severity of reported Adverse Events, compared with placebo |
| Change in ACR20 | 12 weeks | The change in American College of Rheumatology 20% (ACR20) compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ACR50 | 12 weeks | The change in American College of Rheumatology 50% (ACR50) compared to baseline |
| Change in ACR70 | 12 weeks | The change in American College of Rheumatology 70% (ACR70) compared to baseline |
| Change in (CDAI) | 12 weeks | The change Clinical Disease Activity Index (CDAI) compared to baseline |
| Change in DAS-28 | 12 weeks | The change in DAS-28, based on a CRP value, compare to baseline |
Countries
Moldova
Outcome results
None listed