multicenter, randomized, double-blind, controlled, Phase 2b/3 study to compare efficacy and safety of AB1010 at 3 and 6 mg/kg/day in treatment of patients which active rheumatoid arthritis

Phase 2/3

• Conditions: Patients with active rheumatoid arthritis

• Registration Number: CTRI/2014/09/005044
• Lead Sponsor: AB SCIENCE

Brief Summary

Any formal presentation or publication of data collected from this study will be considered as a joint publication by the investigator(s) and the appropriate personnel of AB Science. For this multicentre study, it is mandatory that the first publication is based on data from all centres, analyzed as stipulated in the protocol by AB Science statisticians, and not by the investigators themselves. Investigators agree not to present data gathered from one centre or a small group of centres before the full, initial publication, unless formally agreed to by all other investigators and AB Science.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-30
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months.
• Patient with ACR functional class I-III.
• Patient who have active RA.
• Patient who failed (defined as active RA with stable dose during 3 months) methotrexate at a dose ≥ 15 mg/week or any DMARD including biologics drugs if patients previously failed methotrexate at a dose ≥ 15 mg/week or methotrexate at a dose ≥ 15 mg/week in combination with any DMARD including biologics drugs (Biologic drugs being defined as any of the following therapies: anti-TNFα, Anti-CD20, Anti-IL1, Anti-IL6, CTLA4).
• Patient with a disease onset at > 16 years of age.

Exclusion Criteria

• A patient must not be enrolled if he/she fulfills one of the following exclusion criteria: 1.Patient from whom the use of methotrexate is contraindicated as per its SPC (i.e. patient with severe renal or liver failure, patient with pre-existing blood dyscrasia, patient with alcohol abuse, patient with acute or chronic infection, patient with methotrexate intolerance, patient being treated with live attenuated vaccine) 2.Patient with documented fibromyalgia 3.Patient who have had a major surgery within 2 weeks prior to study entry 4.Patient with lactose intolerance 5.Patient presenting with cardiac disorders defined by at least one of the following conditions: •Patient with recent cardiac history (within 6 months) of: -Acute coronary syndrome -Acute heart failure (class III or IV of the NYHA classification) -Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death) •Patient with cardiac failure class III or IV of the NYHA classification •Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block) •Syncope without known aetiology within 3 months •Uncontrolled severe hypertension, according to judgment of the investigator, or symptomatic hypertension 6.Patient with history of primary malignancy < 5 years; except treated basal cell skin cancer or cervical carcinoma in situ 7.Patient with a severe and/or uncontrolled medical condition 8.Pregnant or lactating woman 9.Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
• 10.Patient who were treated with methotrexate >20 mg cannot be included in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative response on ACR20 (ie. response from week 8 to week 24).	Cumulative response on ACR20 (ie. response from week 8 to week 24).

Secondary Outcome Measures

Name	Time	Method
Cumulative response on ACR50 (ie. response from week 8 to week 24),	Cumulative response on ACR70 (ie. response from week 8 to week 24),

Trial Locations

Locations (4)

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Sri Venkateshwra Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Sujan Surgical Cancer Hospital And Amravati Cancer foundation; 🇮🇳 Amravati, MAHARASHTRA, India

King George Hospital

🇮🇳Visakhapatnam, ANDHRA PRADESH, India

Dr Ashok Kumar

Principal investigator

9849123602

ashok_ortho59@rediffmail.com