Clinical trial NCT01611688: First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis
Official title: First Human Dose Trial of NNC0215-0384 in Subjects With 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: 2012-06-05
Enrollment: 36
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 this trial is to describe the safety and tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of NNC0215-0384 in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) treatment.


Eligibility criteria: Inclusion Criteria:

* Active RA, characterised by a DAS28 (CRP)(Disease Activity Score based on 28 joints and CRP) above 3.2 and a minimum of two swollen joints based on a 68/66 joint count at screening
* Concomitant treatment with MTX (7.5 - 25 mg/week both inclusive) for at least 16 weeks, with a stable dose for at least 6 weeks prior to dosing

Exclusion Criteria:

* Subjects with chronic inflammatory autoimmune disease other than RA
* History of or current inflammatory joint disease other than RA such as gout (crystal proven), psoriatic arthritis, juvenile idiopathic arthritis, current reactive arthritis or Lyme disease
* Any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) requiring systemic anti-infectious treatment within 4 weeks prior to randomisation
* Clinically significant cardiac or cardiovascular disease
* Past or current malignancy
* Latent or active tuberculosis (TB) as documented by: A positive QuantiFeron® test (test can be performed up to 2 months prior to dosing). One retest is allowed in case of inconclusive results.- A history of active TB within the last 3 years even, if treated effectively. - A history of active TB more than 3 years ago, if there is no documentation that the prior anti-TB treatment was appropriate in duration and type

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 10 weeks after trial product administration
Secondary outcomes:
measure: I.v. administration: AUC, Area under the curve
timeFrame: Up to 10 weeks after drug administration
measure: I.v. administration: terminal half-life (t½)
timeFrame: Up to 10 weeks after drug administration
measure: S.c. administration: AUC, Area under the curve
timeFrame: Up to 10 weeks after drug administration
measure: S.c. administration: terminal half-life (t½)
timeFrame: Up to 10 weeks after drug administration
measure: Maximum level and duration of full C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils
timeFrame: Up to 10 weeks after drug administration
measure: Maximum and minimum levels of relevant serum and plasma biomarkers related to NNC0215-0384 safety, efficacy or mechanism of action (MoA)
timeFrame: Up to 10 weeks after drug administration
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References: