Usability of an AI for M923 in Subjects With Moderate to Severe RA

Momenta Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Device: Autoinjector

Biological: M923

Study type

Interventional

Funder types

Industry

Identifiers

NCT02722044

911502

Details and patient eligibility

About

The purpose of this study is to evaluate the usability of an auto-injector (AI) for the delivery of M923 in patients with rheumatoid arthritis (RA)

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants ≥18 years old at the time of Screening
Able to understand and communicate with the Investigator and comply with the requirements of the study, and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
RA diagnosed for at least 6 months before Screening
Meets classification criteria for rheumatoid arthritis (RA) by 2010 American College of Rheumatology/European League Against Rheumatism criteria
Active disease at Screening and Baseline
Participants must have at least 1 documented swollen and/or tender joint in their hand or wrist of the dominant hand as assessed by the Investigator or designated assessor
Must be willing and able to attempt self-administration of subcutaneous (SC) injection(s)
Male participants and their female partners must be willing to comply with the contraception restrictions for this study from the time of the first administration of investigational product (IP) until 3 months after the last dose.
Female participants must have a negative pregnancy test at screening and on admission to the clinic, and must not be lactating and must be using an acceptable method of contraception throughout the study and for 3 months after the last dose, or be of non-childbearing potential. Non-pregnant female partners of male participants who are of childbearing potential should use an effective form of contraception.

Exclusion criteria

Prior use of systemic tumor necrosis factor (TNF) inhibitor therapy.
Prior use of rituximab
Prior use of abatacept, tocilizumab and tofacitinib within 4 weeks prior to Screening
Current use of a conventional disease modifying anti-rheumatic drugs (DMARD) other than the following: methotrexate orally (≤25 mg/day), hydroxychloroquine (≤400 mg/day) or sulfasalazine (≤3 g/day)) at a stable dose for at least 4 weeks prior to Screening. If discontinued, methotrexate, hydroxychloroquine, and sulfasalazine must have been discontinued at least 4 weeks prior to Baseline. No other conventional DMARDs are permitted and no combination therapy is permitted.
Prior use of cytotoxic or alkylating agents or immunosuppressants must have been discontinued for at least 90 days prior to Baseline
Current use of oral corticosteroids at a dose >10 mg/day prednisone or equivalent or change of dose within 2 weeks prior to Screening
Current use of more than 1 nonsteroidal anti-inflammatory drug.
Prior use of injectable corticosteroids (intramuscular [IM], intra-articular [IA], or intravenous [IV]) within 6 weeks prior to Baseline
Prior or current use of other self-injected drugs, eg, insulin
All other prior non-RA concomitant treatments must be on a stable dose for at least 4 weeks before Baseline
Meets Class IV Steinbrocker criteria for disability/activities of daily living
Laboratory abnormalities at Screening deemed clinically significant by the Investigator and/or Sponsor.
Presence of fibromyalgia, another autoimmune rheumatologic illness or inflammatory arthritis, eg, systemic lupus erythematosus, gout. The presence of secondary Sjogren's syndrome is permitted.
Joint surgery within the last 8 weeks prior to Screening
Severe, progressive, or uncontrolled renal, hepatic, metabolic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurologic disease, including pleural effusions or ascites, which in the opinion of the Investigator would preclude the participant from adhering to or completing the study or where participation in the study exposes the participant to unfavorable benefit/risk
History or presence of signs and/or symptoms or a diagnosis of a demyelinating disorder
History or presence of Class III or IV New York Heart Association congestive heart failure
History or presence of symptoms suggestive of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
Existing malignancy or history of any malignancy except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ, with no more than 3 lifetime basal cell or squamous cell carcinomas
Chronic infections, recurrent infections (3 or more of the same infection requiring anti-infective treatment in any rolling 12-month period); any recent infection (ie, in the last 30 days) requiring hospitalization or any infection requiring parenteral anti-infective therapy within 30 days or oral infective therapies within 14 days of Baseline; herpes zoster within 6 months of Baseline or more than 2 lifetime episodes of herpes zoster; or history of systemic fungal infection or opportunistic infection (eg, coccidioidomycosis, histoplasmosis, toxoplasmosis)
History or presence of human immunodeficiency virus (HIV), Hepatitis B or C virus
History of active tuberculosis (TB) or untreated or inadequately treated latent TB.
Participant has been exposed to an investigational product (IP) within 30 days (or 5 half-lives) prior to enrollment, whichever is longer, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
Participant is a family member or employee of the Investigator or Baxalta or its partners