Clinical trial NCT01955603: A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis
Official title: A Randomised, Placebo-controlled, Double-blind Within Cohort, Dose Escalation, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered Subcutaneously to Subjects With Moderate to Severe Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Rheumatoid Arthritis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-10-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0215-0384 administered to subjects with moderate to severe rheumatoid arthritis (RA) concomitantly treated with methotrexate (MTX).


Eligibility criteria: Inclusion Criteria:

* Male or female, age between 18 and 75 years (both years inclusive), for Russia only: Age between 18-65 years (both years inclusive)
* Moderate to severe RA, confirmed by a Disease Activity Score based on 28 joints and C-reactive protein (DAS28 (CRP)) equal to or above 4.5 and a minimum of five tender and five swollen joints based on a 28 joint count (a joint can score as both tender and swollen)
* MTX (10-25 mg/week both inclusive) for at least 16 weeks, with an unchanged dose for at least 6 weeks prior to screening and until randomisation
* Females who are not of child-bearing potential must have been post-menopausal for at least 1 year confirmed by follicle-stimulating hormone (FSH) equal to or above 26.7 U/L or be surgically sterile

Exclusion Criteria:

* Past or current inflammatory joint disease other than RA (e.g. gout \[crystal proven\], psoriatic arthritis, juvenile idiopathic arthritis, reactive arthritis or Lyme disease
* Any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) within 4 weeks prior to randomisation
* Clinically significant cardiac or cardiovascular disease
* Past or current malignancy
* Evaluation of tuberculosis screening indicative of latent or active tuberculosis (TB)

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: From first dosing until 19 weeks after first dosing
Secondary outcomes:
measure: Concentration of NNC0215-0384 in serum
timeFrame: 7 days after each dose
measure: Concentration of NNC0215-0384 in serum
timeFrame: 3 days after first and last dose
measure: Duration of full and duration of detectable levels of C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils from baseline
timeFrame: From week 0 until 19 weeks after first dosing
measure: Change in health assessment questionnaire - disability index (HAQ-DI) from baseline
timeFrame: Week 0, week 7 first dosing
measure: Incidence and characterisation of antibodies directed against NNC0215-0384 and, if present, their in vitro neutralising activity
timeFrame: From first dosing until 19 weeks after first dosing
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Budapest
country: Hungary
city: Krakow
country: Poland
city: Moscow
country: Russian Federation
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: