A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect

Phase 1

Conditions: rheumatoid arthritis
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2019-001185-15-BG

Lead Sponsor: SynAct Pharma ApS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 135

Inclusion Criteria

Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. The following are requirements for entry into the study.
1.Written informed consent has been obtained prior to initiating any study specific procedures
2.Male and female subjects, 18 to 85 years of age
3.Confirmed diagnosis of RA according to the 2010 ACR/EULAR RA classification criteria
4.Polyarthritis with joint swelling and tenderness of a minimum of three joints out of 68 joints tested
5.Candidate for MTX treatment
6.Is about to begin treatment with MTX
7.Tested positive for anti-CCP or RF
8.Severe active RA (CDAI > 22) at screening and baseline
9.Negative QFG-IT (Mantoux test can be used if QFG-IT is not possible)
10.Subjects should be able to complete (read and write) the PRO questionnaires
11.Females of child-bearing potential may only participate if using reliable means of contraception or are post-menopausal (menstrual periods stopped at least 12 months ahead of the enrolment in the trial). Surgically sterilized women at least 6 months prior to screening
12.Females of childbearing potential must have a negative pregnancy test at screening and baseline.

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 91
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion Criteria

Subjects meeting any of the following criteria are not eligible for participation in the study:
1.Participation in any other study involving investigational drug(s) within 4 weeks prior to study entry
2.Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within 1 month following randomization
3.Rheumatic autoimmune disease other than RA, including SLE, MCTD, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty’s syndrome). Sjögren syndrome with RA is allowable
4.Functional class IV as defined by the ACR Criteria for Classification of Functional Status in RA or wheelchair/bedbound
5.Prior history of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
6.Subjects with fibromyalgia
7.Initiation or change in dose for NSAIDs (including low-dose aspirin and COX-2 inhibitors) within 2 weeks prior to dosing with the IMP
8.Corticosteroids are prohibited within 2 weeks prior to screening (and during the entire treatment period and until the final visit (Visit 7)
9.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease
10.Have prior renal transplant, current renal dialysis or severe renal insufficiency (determined by a derived glomerular filtration rate (GFR) using Cockcroft Gault formula of =30 ml/min/1,73m² calculated by the local lab)
11.Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
12.Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured)
13.Pregnant women or nursing (breastfeeding) mothers
14.History of alcohol, drug, or chemical abuse within the 6 months prior to screening
15.Neuropathies or other painful conditions that might interfere with pain evaluation
16.Body weight of >150 kg.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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