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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Recruitment Status : Withdrawn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

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.

Condition or disease Intervention/treatment Phase
Inflammation Rheumatoid Arthritis Drug: NNC0109-0012 Drug: Adalimumab Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NNC0109-0012 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: 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).


Active Comparator: Adalimumab 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).





Primary Outcome Measures :
  1. Change in the total histopathological synovitis score [ Time Frame: Week 0, week 12 ]

Secondary Outcome Measures :
  1. Change in dynamic contrast enhanced MRI (DCE-MRI) measures of initial rate of enhancement (IRE) [ Time Frame: Week 0, week 12 ]
  2. Change in dynamic contrast enhanced MRI (DCE-MRI) measures of maximal enhancement (ME) [ Time Frame: Week 0, week 12 ]
  3. Changes in RA-MRI scores (RAMRIS (Rheumatoid arthritis magnetic resonance imaging)) of synovitis [ Time Frame: Week 0, week 12 ]
  4. Changes in RA-MRI scores (RAMRIS) of oedema [ Time Frame: Week 0, week 12 ]
  5. Changes in RA-MRI scores (RAMRIS) of erosion [ Time Frame: Week 0, week 12 ]
  6. Change in high frequency ultrasound with Power Doppler measures of total synovitis [ Time Frame: Week 0, week 12 ]
  7. Change in high frequency ultrasound with Power Doppler measures of total tenosynovitis scores [ Time Frame: Week 0, week 12 ]
  8. Change in disease activity 28 - C-reactive protein (DAS28 (CRP) [ Time Frame: Week 0, week 12 ]
  9. Incidence of Adverse Events (AE) [ Time Frame: Week 0, week 24 ]
  10. Incidence of local intolerability at the injection site [ Time Frame: Week 0, week 24 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02097264


Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02097264     History of Changes
Other Study ID Numbers: NN8226-4064
2013-001492-20 ( EudraCT Number )
U1111-1141-3512 ( Other Identifier: WHO )
REec-2014-0740 ( Registry Identifier: Spanish Register of Clinical Studies (REec) )
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Adalimumab
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents