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In Patients with Active Rheumatoid Arthritis

Open-Label, Comparative, Randomized Study of Efficacy and Safety of Exemptia (INN: adalimumab), Solution for Subcutaneous Injection and Humira®, Solution for Subcutaneous Injection in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate Therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/009988
Enrollment
288
Registered
2017-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with Active Rheumatoid Arthritis

Interventions

Intervention1: Trade name Exemptia Composition 0.8 mL of the solution contains: Active ingredient: adalimumab - 40.0 mg. Excipients: succinic acid - 0.944 mg
sodium chloride - 4.672 mg
L-arginine monohydrochloride â?? 4 mg
sorbitol - 8 mg
polysorbate 80 - 0.08 mg
sodium hydroxide - q. s. to pH 5.2
water for injection - q. s. to 0.8 mL. : Pharmaceutical form solution for subcutaneous injection Manufacturer Cadila Healthcare Ltd., India Dosing regimen used in the study 40 mg in subcutaneous injec
citric acid monohydrate - 1.044 mg
sodium citrate - 0.244 mg
sodium hydrogen phosphate dihydrate - 1.224 mg
sodium dihydrogen phosphate dihydrate - 0.688 mg
sodium chloride - 4.932 mg
polysorbate 80 - 0.8 mg
water for injection - 759.028 mg - 759.048 mg
sodium hydroxide - 0.02 mg - 0.04 mg. : Pharmaceutical form solution for subcutaneous injection Manufacturer Vetter Pharma-Fertigung GmbH & Co. KG, Germany Dosing regimen used in the study 40 mg in su

Sponsors

Rus Biopharm LLC
Lead Sponsor
Nexus Clinical Research India Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. The Informed Consent Form has been signed and dated by the patient personally indicating that the patient was informed of all the significant aspects of the study. 2. Males or females aged 18 to 75 years inclusive at the moment of signing the Informed Consent Form. 3. The patients who are capable of complying with the regime of scheduled visits, the plan of treatment, the schedule of study-related laboratory tests and procedures. 4. The patient has agreed to use reliable methods of contraception throughout the whole study period and for 6 weeks after the end of the study.

Exclusion criteria

Exclusion criteria: 1. Clinically relevant laboratory abnormalities at the time of the screening: Hemoglobin Absolute neutrophil count (ANC)�1.5�109/L. White blood cell count Platelet count AST/ALT level �2xULN (the upper limit of normal). AST/ALT level �1.5xULN. Serum creatinine � 132.6 µmol/L

Design outcomes

Primary

MeasureTime frame
Proportion of the patients demonstrating response to therapy according the ACR20 criterionTimepoint: by Week 24 of the study.—

Secondary

MeasureTime frame
Proportion of the patients demonstrating response to therapy according to ACR20, ACR50, ACR70 criteriaTimepoint: by Weeks 4, 8, 12, 24 and 48;Proportion of the patients demonstrating good response, moderate response, no response to therapy according to DAS-28 criterionTimepoint: by Weeks 4, 8, 12, 24 and 48;Proportion of the patients demonstrating remission (2.6) and low-activity stage (3.2) according to DAS-28 criterionTimepoint: by Weeks 4, 8, 12, 24 and 48—

Countries

India, Russian Federation

Contacts

Public ContactDr Mangesh khadakban

Nexus Clinical Research (India) Ltd.

hbo@nexuscro.com9167243914

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026