A Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With RA

NCT01709760 | Unknown Phase 3 DMC

• 1 other identifier: TSHEN1101
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 8

Brief Summary

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination with Methotrexate versus Methotrexate Alone in Patients with Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis

Keywords

ENIA11; MTX; RA; TNF

Outcome Measures

Primary Outcomes (1)

• ACR20 responder at last treatment visit

  The primary efficacy endpoint is defined as ACR20 responder at last treatment visit (Week 24).

  Week 24

Study Arms (2)

methotrexate & ENIA11

EXPERIMENTAL

ENIA11 25 mg, sc twice weekly

Drug: Methotrexate; Drug: ENIA11

methotrexate & Placebo

ACTIVE COMPARATOR

Placebo, sc twice weekly

Drug: Methotrexate; Drug: Placebo

Interventions

Methotrexate DRUG

Methotrexate 15-25 mg/week

methotrexate & ENIA11; methotrexate & Placebo

ENIA11 DRUG

ENIA11 25 mg, sc twice weekly

Also known as: TuNEX

methotrexate & ENIA11

Placebo DRUG

Placebo, sc twice weekly

methotrexate & Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥ 20 years old;
• Patient meet ACR criteria for rheumatoid arthritis over 6 month duration;
• Patient with active disease at the time of screening as defined by six or more swollen joints and six or more tender joints;
• Presence of at least one of the following criteria:
• Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h,
• C-Reactive Protein (CRP) ≥ 10 mg/L,
• RA functional class I, II, or III;
• Patients have been treated on methotrexate for at least 3 month, and maintained at stable dose of 15-25 mg/week for at least 8 weeks; MTX low dose as 10 mg per week is allowed for patients who had a documented history of constitutional symptoms at higher doses.
• Patient is willing and able to comply with study procedures and sign informed consent.

You may not qualify if:

• Active autoimmune disease (other than RA) requiring immunosuppressive therapy;
• In the opinion of the investigator, the patient shows persistent signs of immunosuppression;
• Known hypersensitivity to etanercept or ENIA11 or any of its components;
• Previous unsuccessful treatment with etanercept, anti-TNF monoclonal antibodies or a soluble TNF receptor (e.g., infliximab);
• Suspected or diagnosed pulmonary tuberculosis, or other chronic or current infectious disease at discretion of investigator;
• Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, hematological, gastrointestinal or psychiatric disease as determined by the clinical judgment of the investigator;
• Patients with any of the following laboratory abnormalities: ALT/AST \> 3 times ULN, creatinine \> 2 mg/dl, WBC \< 3,000/mm3, Hgb \< 8.5 g/dL, platelet count \< 100,000/mm3;
• Patients have received live attenuated vaccination program within 3 months or BCG vaccine within 12 months prior enrollment;
• Female patient of childbearing potential who:
• is lactating; or
• has positive urine pregnancy test at Visit 1; or
• refuse to adopt reliable method of contraception during the study;
• Diagnosis of primary fibromyalgia or other joint inflammatory disease including but not limited to gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease;
• Known or suspected positive serology for human immunodeficiency, hepatitis B or C virus;
• Patient has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product;

Sponsors & Collaborators

• Mycenax Biotech Inc.: lead

Study Sites (8)

Changhua Christian Hospital

Changhua, Taiwan

Location

Buddhist Tzu Chi General Hospital

Chiayi City, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

Taipei City Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

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)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joung-Liang Lan, PHD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Chung-Ming Huang, MD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Der-Yuan Chen, PHD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

• Ling-Ying Lu, PHD

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

• Ning-Sheng Lai, PHD

  Buddhist Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

• Tien-Tsai Cheng, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Gregory J Tsay, PHD

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

• Ying-Ming Chiu, MD

  Changhua Christian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 18, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2019
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

TW (8)