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First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01611688
First Posted: June 5, 2012
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Inflammation Rheumatoid Arthritis Drug: NNC0215-0384 Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of adverse events (AEs) [ Time Frame: Up to 10 weeks after trial product administration ]

Secondary Outcome Measures:
  • I.v. administration: AUC, Area under the curve [ Time Frame: Up to 10 weeks after drug administration ]
  • I.v. administration: terminal half-life (t½) [ Time Frame: Up to 10 weeks after drug administration ]
  • S.c. administration: AUC, Area under the curve [ Time Frame: Up to 10 weeks after drug administration ]
  • S.c. administration: terminal half-life (t½) [ Time Frame: Up to 10 weeks after drug administration ]
  • Maximum level and duration of full C5a receptor (C5aR) occupancy by NNC0215-0384 on neutrophils [ Time Frame: Up to 10 weeks after drug administration ]
  • Maximum and minimum levels of relevant serum and plasma biomarkers related to NNC0215-0384 safety, efficacy or mechanism of action (MoA) [ Time Frame: Up to 10 weeks after drug administration ]

Enrollment: 36
Actual Study Start Date: June 4, 2012
Study Completion Date: June 17, 2013
Primary Completion Date: June 17, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: NNC0215-0384
I.v.(intravenous) dose-escalation. Highest dose planned for i.v. administration is 10 mg/kg
Drug: NNC0215-0384
The s.c. (subcutaneous, under the skin) part will not start until at least two i.v. dose levels have been evaluated for safety and pharmacokinetics. Highest dose planned for s.c. administration is 4 mg/kg
Placebo Comparator: Placebo Drug: placebo
Administered i.v.(intravenous) or s.c. (subcutaneous, under the skin).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611688


Locations
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10117
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01611688     History of Changes
Other Study ID Numbers: NN8210-3926
2011-003008-19 ( EudraCT Number )
U1111-1122-3474 ( Other Identifier: WHO )
First Submitted: June 1, 2012
First Posted: June 5, 2012
Last Update Posted: February 27, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs