A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate
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ClinicalTrials.gov Identifier: NCT01636843 |
Recruitment Status :
Terminated
First Posted : July 10, 2012
Last Update Posted : September 5, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inflammation Rheumatoid Arthritis | Drug: NNC0109-0012 Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 298 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate |
Actual Study Start Date : | October 30, 2012 |
Actual Primary Completion Date : | November 10, 2014 |
Actual Study Completion Date : | November 10, 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: 60 mg |
Drug: NNC0109-0012
Administered subcutaneously (s.c., under the skin), once weekly. |
Experimental: 120 mg |
Drug: NNC0109-0012
Administered subcutaneously (s.c., under the skin), once weekly. |
Experimental: 240 mg |
Drug: NNC0109-0012
Administered subcutaneously (s.c., under the skin), once weekly. |
Experimental: Placebo |
Drug: placebo
Administered subcutaneously (s.c., under the skin), once weekly. |
- ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures) [ Time Frame: At week 12 (responder or non-responder) ]
- ACR20, ACR50 and ACR70 improvement of ACR score from baseline [ Time Frame: At weeks 12 and 24 ]
- Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline [ Time Frame: At weeks 12 and 24 ]
- Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below) [ Time Frame: At weeks 12 and 24 ]
- European League Against Rheumatism (EULAR) criteria response [ Time Frame: At weeks 12 and 24 ]
- Change from baseline in the overall scores of Short Form Health Survey (SF-36v2) [ Time Frame: At weeks 12 and 24 ]
- Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: At weeks 12 and 24 ]
- Incidence and type of adverse events (AEs) [ Time Frame: At weeks 12 and 24 ]
- Change from baseline in van der Heijde modified Sharp score [ Time Frame: At weeks 12 and 24 ]
- ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline) [ Time Frame: Week 52 ]
- Incidence and type of adverse events (AEs) [ Time Frame: Week 52 ]

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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 |

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): NCT01636843

Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01636843 |
Other Study ID Numbers: |
NN8226-3613 2012-000610-11 ( EudraCT Number ) U1111-1127-9324 ( Other Identifier: WHO ) |
First Posted: | July 10, 2012 Key Record Dates |
Last Update Posted: | September 5, 2018 |
Last Verified: | September 2018 |
Arthritis Arthritis, Rheumatoid Inflammation Joint Diseases Musculoskeletal Diseases |
Pathologic Processes Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |