This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment m923
Phase phase 3
Sponsor Baxalta US Inc.
Start date April 2016
End date December 2016
Trial size 51 participants
Trial identifier NCT02722044, 911502


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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
All study participants to receive M923 administered via a subcutaneous auto-injector (AI)
m923 Adalimumab
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)

Primary Outcomes

Usability of the auto-injector (AI)
time frame: Week 4

Secondary Outcomes

Observer assessment of usability of the autoinjector by the participants at baseline and week 4
time frame: Baseline and week 4
Usability of the auto-injector (AI)
time frame: Baseline and week 2
Observer assessment of usability of the autoinjector by the participants at baseline and week 2
time frame: Baseline and week 2
Clinically significant changes in vital signs
time frame: Throughout the study period of approximately 11 months
Clinically significant changes in clinical laboratory assessments
time frame: Screening, baseline, and weeks 4, 12, 24, and 28
Clinically significant changes in Twelve-lead electrocardiogram (ECG)
time frame: Throughout the study period of approximately 11 months
Number of adverse events leading to premature study withdrawal
time frame: Throughout the study period of approximately 11 months
Immunogenicity of M923 assessed as proportion of participants with evidence of seroconversion as measured by titer of anti-drug antibody (ADA)
time frame: Baseline, and weeks 4, 12, 24, and 28
Immunogenicity of M923 assessed as proportion of participants with neutralizing anti-drug antibody (nADAs)
time frame: Baseline, and weeks 4, 12, 24, and 28

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Participants ≥18 years old at the time of Screening 2. 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. 3. RA diagnosed for at least 6 months before Screening 4. Meets classification criteria for rheumatoid arthritis (RA) by 2010 American College of Rheumatology/European League Against Rheumatism criteria 5. Active disease at Screening and Baseline 6. 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 7. Must be willing and able to attempt self-administration of subcutaneous (SC) injection(s) 8. 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. 9. 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: 1. Prior use of systemic tumor necrosis factor (TNF) inhibitor therapy. 2. Prior use of rituximab 3. Prior use of abatacept, tocilizumab and tofacitinib within 4 weeks prior to Screening 4. 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. 5. Prior use of cytotoxic or alkylating agents or immunosuppressants must have been discontinued for at least 90 days prior to Baseline 6. Current use of oral corticosteroids at a dose >10 mg/day prednisone or equivalent or change of dose within 2 weeks prior to Screening 7. Current use of more than 1 nonsteroidal anti-inflammatory drug. 8. Prior use of injectable corticosteroids (intramuscular [IM], intra-articular [IA], or intravenous [IV]) within 6 weeks prior to Baseline 9. Prior or current use of other self-injected drugs, eg, insulin 10. All other prior non-RA concomitant treatments must be on a stable dose for at least 4 weeks before Baseline 11. Meets Class IV Steinbrocker criteria for disability/activities of daily living 12. Laboratory abnormalities at Screening deemed clinically significant by the Investigator and/or Sponsor. 13. Presence of fibromyalgia, another autoimmune rheumatologic illness or inflammatory arthritis, eg, systemic lupus erythematosus, gout. The presence of secondary Sjogren's syndrome is permitted. 14. Joint surgery within the last 8 weeks prior to Screening 15. 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 16. History or presence of signs and/or symptoms or a diagnosis of a demyelinating disorder 17. History or presence of Class III or IV New York Heart Association congestive heart failure 18. History or presence of symptoms suggestive of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma 19. 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 20. 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) 21. History or presence of human immunodeficiency virus (HIV), Hepatitis B or C virus 22. History of active tuberculosis (TB) or untreated or inadequately treated latent TB. 23. 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 24. Participant is a family member or employee of the Investigator or Baxalta or its partners

Additional Information

Official title An Open-label Single-arm Multicenter Study to Evaluate Usability of a Subcutaneous (SC) Autoinjector (AI) for a Proposed Adalimumab Biosimilar (M923) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Baxalta US Inc..