A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics
Status: | Terminated |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 9/7/2018 |
Start Date: | August 2012 |
End Date: | November 2014 |
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 Anti-TNFa Biologics
This trial is conducted in Europe, North America and South America. The aim of this trial is
to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared
to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to
patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa
biologics and are on a stable background of methotrexate (MTX) therapy.
to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared
to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to
patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa
biologics and are on a stable background of methotrexate (MTX) therapy.
Inclusion Criteria:
- Informed consent must be obtained before any trial-related activities. Trial-related
activities are any procedures that are carried out as part of the trial, including
activities to determine suitability for the trial.
- A documented 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
- Active RA, characterised by: a. above 5 tender and above 5 swollen joints based on a
28 joint count b. CRP (C-reactive protein) above or equal to 1.0 mg/dL (10 mg/L)
- Patients must be anti-TNF (anti-Tumour Necrosis Factor) inadequate responders to at
least one but not more than two anti-TNF biologics with active disease documented in
medical records at the time of discontinuation
Exclusion Criteria:
- Patients with arthritis due to other autoimmune diseases than RA
- Any active or ongoing 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)
- History of severe, systemic viral or fungal infections within the past 6 months prior
to screening visit, unless treated and/or resolved with appropriate therapy
- Patients with active 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
- Females of childbearing potential who are pregnant or breast feeding or intend to
become pregnant
- Any other disease or clinically significant abnormality in laboratory parameters
which, according to the Investigator, might compromise the safety of the patient,
interfere with participation in the trial or compromise the trial objective
We found this trial at
85
sites
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