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

NCT02722044 | Completed Phase 3 Results

• 1 other identifier: 911502
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 7

Brief Summary

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)

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Usability of the Auto-injector (AI) at Week 4

  The primary usability measure was the participant rating captured in the PRE- and POST-Self-injection Assessment Questionnaire (SIAQ) modules at Week 4. The PRE-SIAQ module is a 7-item questionnaire that investigates feelings about injections, self-confidence (regarding self-administration), and satisfaction with self-injection. The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions during or after injection (injection-site reactions), ease of use of the self-injection device, and satisfaction with self-injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scale, where a score of 1 corresponds to a participant's worst experience and a score of 5 (or 6) corresponds to a participant's best experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item.

  Week 4

Secondary Outcomes (23)

• Number of Participants With Successful Injections as Assessed by the Observer at Week 4

  Week 4

• Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 4

  Week 4

• Usability of the Auto-injector at Baseline

  Baseline (Day 1)

• Usability of the Auto-injector at Week 2

  Week 2

• Number of Participants With Successful Injections as Assessed by the Observer at Baseline

  Baseline (Day 1)

Study Arms (1)

All Study Participants

EXPERIMENTAL

All study participants to receive M923 administered via a subcutaneous auto-injector (AI)

Biological: M923; Device: Autoinjector

Interventions

M923 BIOLOGICAL

Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)

Also known as: Adalimumab

All Study Participants

Autoinjector DEVICE

Subcutaneous administration

All Study Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Momenta Pharmaceuticals, Inc.: lead

Study Sites (7)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Medication Management, LLC

Greensboro, North Carolina, 27408, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Altoona Center for Clinical Research, PC

Duncansville, Pennsylvania, 16635, United States

Location

Austin Regional Clinic, PA

Austin, Texas, 78731, United States

Location

Accurate Clinical Management

Houston, Texas, 77004, United States

Location

Accurate Clinical Research, Inc.

Houston, Texas, 77034, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Jim Jin
• Organization: Momenta

jjin@momentapharma.com

+16173954905

Study Officials

• John Caminis, MD

  Baxalta US Inc., now part of Shire

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 29, 2016
• Study Start: April 1, 2016
• Primary Completion: February 21, 2017
• Study Completion: February 21, 2017
• Last Updated: May 16, 2018
• Results First Posted: May 1, 2018

Record last verified: 2018-05

Locations

US (7)