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A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

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ClinicalTrials.gov Identifier: NCT02097264
Recruitment Status : Withdrawn
First Posted : March 27, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE March 24, 2014
First Posted Date  ICMJE March 27, 2014
Last Update Posted Date August 15, 2014
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
Change in the total histopathological synovitis score [ Time Frame: Week 0, week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • Change in dynamic contrast enhanced MRI (DCE-MRI) measures of initial rate of enhancement (IRE) [ Time Frame: Week 0, week 12 ]
  • Change in dynamic contrast enhanced MRI (DCE-MRI) measures of maximal enhancement (ME) [ Time Frame: Week 0, week 12 ]
  • Changes in RA-MRI scores (RAMRIS (Rheumatoid arthritis magnetic resonance imaging)) of synovitis [ Time Frame: Week 0, week 12 ]
  • Changes in RA-MRI scores (RAMRIS) of oedema [ Time Frame: Week 0, week 12 ]
  • Changes in RA-MRI scores (RAMRIS) of erosion [ Time Frame: Week 0, week 12 ]
  • Change in high frequency ultrasound with Power Doppler measures of total synovitis [ Time Frame: Week 0, week 12 ]
  • Change in high frequency ultrasound with Power Doppler measures of total tenosynovitis scores [ Time Frame: Week 0, week 12 ]
  • Change in disease activity 28 - C-reactive protein (DAS28 (CRP) [ Time Frame: Week 0, week 12 ]
  • Incidence of Adverse Events (AE) [ Time Frame: Week 0, week 24 ]
  • Incidence of local intolerability at the injection site [ Time Frame: Week 0, week 24 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Official Title  ICMJE A Randomised, Active Comparator, Double-blind, Multi Centre, Parallel, Phase 2a Trial, Investigating the Mechanism of Action, of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Brief Summary This trial is conducted in Europe. The aim of the trial is to investigate the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis (RA) and an inadequate response to Methotrexate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Inflammation
  • Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: NNC0109-0012
    Solution for injection administered subcutaneously (s.c. - under the skin). 240 mg NNC0109-0012 will be administered weekly for 12 weeks
  • Drug: Adalimumab
    Solution for injection administered subcutaneously (s.c. - under the skin). Administered every other week for 12 weeks; Each active treatment involves 1 (one) s.c. injection of adalimumab 40 mg/0,8 mL solution for injection for paediatric use (Humira®)
  • Drug: placebo

    Solution for injection administered subcutaneously (s.c. - under the skin).

    1 active adalimumab injection and 2 placebo injections per active treatment (every other week), and 3 placebo injections on placebo visits (alternative weeks).

Study Arms  ICMJE
  • Experimental: NNC0109-0012
    Interventions:
    • Drug: NNC0109-0012
    • Drug: placebo
  • Active Comparator: Adalimumab
    Interventions:
    • Drug: Adalimumab
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 13, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2014)
42
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female age at least 18 and below or equal to 75 years at the time of signing informed consent
  • A diagnosis of RA at least 6 months prior to screening visit, according to the American College of Rheumatology (EULAR/ACR 2010 criteria) or by standard criteria (ACR 1987) if diagnosis was made earlier than 2010
  • Subjects with ACR global functional status of 1 to 3
  • Active RA, characterised by: DAS28 (Disease Activity Score 28) (CRP (C-reactive protein)) above 4.5 and equal to or above 6 tender and equal to or above 6 swollen joints based on a 66/68 joint count
  • Active Synovitis in at least two joints of the wrist and metacarpophalangeal joints, as assessed by high frequency Power Doppler ultrasound scan at screening and randomisation

Exclusion Criteria:

  • Subjects with arthritis due to other autoimmune diseases than RA
  • Body weight above 90.0 kg
  • History of or current inflammatory joint disease other than RA (e.g. gout, psoriatic or reactive arthritis, Lyme disease, juvenile idiopathic arthritis, excluding secondary Sjogren syndrome and hypothyroidism)
  • Any active or on-going bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
  • Subjects with malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit
  • Female who is pregnant, breast feeding, intends to become pregnant or is of childbearing potential, not willing to use two highly effective contraceptive methods (adequate highlyeffective contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system) one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream), for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
  • Male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of highly effective contraception, one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Ireland,   Portugal,   Spain,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT02097264
Other Study ID Numbers  ICMJE NN8226-4064
2013-001492-20 ( EudraCT Number )
U1111-1141-3512 ( Other Identifier: WHO )
REec-2014-0740 ( Registry Identifier: Spanish Register of Clinical Studies (REec) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP