NCT02744196 (ALTERRA) is a Phase 3 clinical trial of Acellbia in Rheumatoid Arthritis, sponsored by Biocad.

Who is sponsoring NCT02744196?

NCT02744196 is sponsored by Biocad.

What drugs are being tested in NCT02744196?

Interventions in NCT02744196: Acellbia, Placebo, Methotrexate.

What condition does NCT02744196 study?

NCT02744196 studies Rheumatoid Arthritis.

Is NCT02744196 still recruiting?

NCT02744196 is currently completed. Last updated 24 January 2018.

Last reviewed 2018-01-24 · How we verify

NCT02744196: ALTERRA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Multicenter Comparative Randomised Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line of Biological Therapy of Patients With Active Rheumatoid Arthritis

Completed Phase 3 Last updated 24 January 2018

What this trial tests

Phase 3 trial testing Acellbia in Rheumatoid Arthritis in 159 participants. Completed in 1 August 2017.

Timeline

1 January 2015

Primary endpoint
1 February 2017

1 August 2017

Quick facts

Lead sponsor	Biocad
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	159
Start date	1 January 2015
Primary completion	1 February 2017
Estimated completion	1 August 2017

Drugs / interventions tested

Acellbia — full drug profile →
Placebo
Methotrexate — full drug profile →

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Biocad — full company profile →

Who can join

Adults 18 to 80, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of patients who developed ACR20 response on 24 week of therapy
Time frame: Week 24
The proportion of patients achieving at least a 20% improvement in ACR criteria at 24 weeks of therapy.

Sponsor's own description

The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with biological therapy, compared to standard therapy with methotrexate.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Biologics or tofacitinib for people with rheumatoid arthritis naive to methotrexate: a systematic review and network meta-analysis.
Singh JA, Hossain A, Mudano AS, Tanjong Ghogomu E, et al · · 2017 · cited 44× · PMID 28481462 · DOI 10.1002/14651858.cd012657
Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network meta-analysis.
Singh JA, Hossain A, Tanjong Ghogomu E, Mudano AS, et al · · 2017 · cited 38× · PMID 28282491 · DOI 10.1002/14651858.cd012591

Verify or expand the search:

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting

Other Biocad trials

Trials by the same sponsor.

NCT07136389 — Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus · Phase 1 · recruiting
NCT05974969 — A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subject · Phase 1 · completed
NCT05802225 — Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer · Phase 3 · active not recruiting
NCT05726630 — Clinical Study of Divozilimab in Patients With Systemic Scleroderma · Phase 3 · active not recruiting
NCT05738993 — A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single I · Phase 1 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02744196 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biocad
Last refreshed: 24 January 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02744196.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing