Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis
This study is currently recruiting participants.
Verified March 2012 by Nichi-Iko Pharmaceutical Co.,Ltd.
Sponsor:
Nichi-Iko Pharmaceutical Co.,Ltd.
Information provided by (Responsible Party):
Nichi-Iko Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01567358
First received: March 23, 2012
Last updated: March 28, 2012
Last verified: March 2012
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Purpose
The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with Methotrexate.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Biological: Infliximab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Infliximab
U.S. FDA Resources
Further study details as provided by Nichi-Iko Pharmaceutical Co.,Ltd.:
Primary Outcome Measures:
- Safety : Incidence of Adverse Events [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- PK : Area under the serum concentration versus time curve(AUC) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Efficacy : ACR core-set [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: NI-071 |
Biological: Infliximab
100mg/vial
|
| Active Comparator: Remicade |
Biological: Infliximab
100mg/vial
|
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with ACR Functional Classification class I-III and disease duration of no less than 3 months
- Patients must receive a minimum of 3 months treatment with methotrexate (MTX) (≥ 6 mg/week) prior to the Screening Visit. Patients must be on a stable dose of MTX (6 mg~16 mg mg/week) for a minimum of 4 weeks prior to the Screening Visit
Exclusion Criteria:
History of following diseases
- Other Connective tissue disorders with joint symptom which may interfere the efficacy assessment
- Chlonic or recurrent infectious disease（bronchial ectasia, sinus inflammation etc.）
- Severe infectious disease（hepatitis, pneumonia、sepsis）
- History of demyelinating disease or multiple sclerosis
- Congestive heart failure
- lymphoproliferative disorder or myelodysplastic syndrome
- History of malignancy
- Interstitial lung disease
- Patients with active or latent tuberculosis or history of tuberculosis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567358
Locations
| Japan | |
| 392001001 | Recruiting |
| Sendai, Miyagi, Japan, 982-0032 | |
| Contact: For site information, send an email with site number to mori@nichiiko.co.jp | |
Sponsors and Collaborators
Nichi-Iko Pharmaceutical Co.,Ltd.
More Information
No publications provided
| Responsible Party: | Nichi-Iko Pharmaceutical Co.,Ltd. |
| ClinicalTrials.gov Identifier: | NCT01567358 History of Changes |
| Other Study ID Numbers: | NI071C1(ACT12719) |
| Study First Received: | March 23, 2012 |
| Last Updated: | March 28, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Infliximab Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 19, 2013