Clinical trial NCT05516979: A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment
Official title: A Double-blind, Multi-center, Randomized, Placebo-controlled Study of the Safety and Efficacy of 12 Weeks Extended Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients naïve to DMARD Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: SynAct Pharma Aps
Sponsor class: INDUSTRY
Collaborators: name: NBCD A/S
First posted: 2022-08-26
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, randomized, double-blind, placebo-controlled study with 12 weeks of treatment with AP1189 or placebo
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Number of reported AEs
timeFrame: 12 weeks
measure: Change in ACR20
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in ACR50
timeFrame: 12 weeks
measure: Change in ACR70
timeFrame: 12 weeks
measure: Change in (CDAI)
timeFrame: 12 weeks
measure: Change in DAS-28
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chișinău
country: Moldova, Republic of
facility: Timofei Mosneaga Republican Clinical Hospital
Study officials:
References: