Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade

NCT02605642 | Completed Results FDA Drug

• 2 other identifiers: ZOBINF1505C1231002
• Study Type: observational
• Target: 351
• Locations: 7 countries
• Sites: 38

Brief Summary

To assess persistence of CT-P13 in patients with Rheumatoid Diseases (Rheumatoid arthritis \[RA\], ankylosing spondylitis \[AS\], and psoriatic arthritis \[PsA\]) who are naïve to biologics or are switching from stable Remicade to CT-P13. The main objectives of the study are:

• To evaluate real-life drug persistence in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
• To characterise the patient populations and drug usage patterns of RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade
• To assess the safety of CT-P13 in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade for up to 2 years

Conditions

Rheumatoid Diseases; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Keywords

CT-P13; Inflectra; Remsima; Remicade; Infliximab; Observational; Follow-up; Safety

Outcome Measures

Primary Outcomes (8)

• Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)

  Persistence (in days) was defined as a continuous variable measured in time from index date until date of drug discontinuation. Drug discontinuation was defined as either switching to another non infliximab BDMARD or elapsing of a drug free interval of 16 weeks from CT-P13. For participants undergoing a switch to CT-P13 from Remicade, the index date was considered the date from which Remicade was originally commenced and for participants who initiated treatment with CT-P13 as their first biologic, the index date was considered the date from which CT-P13 was initiated.

  During the observation period of 2 years

• Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study

  Disease duration was defined as the number of months from initial diagnosis of rheumatoid disease (RA, AS or PsA) to the date of informed consent, which was recorded at the time of inclusion in the study (Day 1).

  At Day 1 of 2 year observation period

• Initial Dose of CT-P13 Infusion Administered to Participants

  Initial dose of CT-P13 infusion (dose at the time of CT-P13 treatment initiation) was reported in this outcome measure.

  At Day 1 of 2 year observation period

• Number of Participants by Initial Frequency of CT-P13 Infusion Received

  Initial frequency of CT-P13 infusion was categorized as: once every 4, 6, 8 weeks and other. 'Other' included all other frequencies other than specified. Number of participants by baseline infusion frequency (in weeks) were reported.

  Baseline (Day 1) of 2 year observation period

• Total Dose of CT-P13 Infusion Received During Observation Period

  Total dose of infusion received by the participants were evaluated.

  During the observation period of 2 years

• Number of Participants With Change in CT-P13 Infusion Dose

  Participants who had change in the dose of infusion (either dose reduction or increase in dose) during the observation period were reported.

  During the observation period of 2 years

• Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)

  Concomitant medications included corticosteroids, non-steroidal anti- inflammatory drugs (NSAID'S) and immunosuppressant. Participants were counted in more than one categories. 'Others' included DMARDS and other medications apart from the categories specified.

  During the observation period of 2 years

• Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)

  An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to 2 years, that were absent before treatment or that worsened relative to pretreatment state. Serious infections including sepsis (excluding opportunistic infections and tuberculosis) were the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events.

  During the observation period of 2 years

Secondary Outcomes (11)

• Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at Months 6, 12, 18 and 24

  Baseline, Months 6, 12, 18 and 24

• Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24

  Baseline, Months 6, 12, 18 and 24

• Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24

  Baseline, Weeks 6, 12, 18 and 24

• Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24

  Baseline, Weeks 6, 12, 18 and 24

• Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24

  Baseline, Weeks 6, 12, 18 and 24

Study Arms (1)

CT-P13

biosimilar infliximab

Drug: CT-P13

Interventions

CT-P13 DRUG

biosimilar infliximab

Also known as: Inflectra, Remsima

CT-P13

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target study population will include biologic naïve rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patients starting biologic treatment with CT-P13 or those switched to CT-P13 from stable Remicade treatment

You may qualify if:

• Patients aged ≥18 years old at the time of enrollment
• Patients who are prescribed CT-P13 or Remicade for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis prescribed according to the corresponding summary of product characteristics (SmPC and Product Monograph) as determined by the investigator

You may not qualify if:

• Any reported contraindications for Inflectra according to the SmPC or Product Monograph
• Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrollment

Sponsors & Collaborators

• Pfizer: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (38)

MHAT Trimontium OOD

Plovdiv, 4000, Bulgaria

Location

MHAT Kaspela EOOD

Plovdiv, 4001, Bulgaria

Location

Diagnostic Consultative Center 17 Sofia EOOD

Sofia, 1233, Bulgaria

Location

Lucere Skin Dermatology & Laser Clinic

Edmonton, Alberta, T6X 0N9, Canada

Location

Nexus Clinical Research

St. John's, Newfoundland and Labrador, A1A 5E8, Canada

Location

Dr. Juris Lazovskis Inc.

Sydney, Nova Scotia, B1S 3N1, Canada

Location

The Waterside Clinic

Barrie, Ontario, L4M 6L2, Canada

Location

William Osler Health System

Brampton, Ontario, L6T 3J1, Canada

Location

Adachi Medicine Professional Corporation

Hamilton, Ontario, L8N 1Y2, Canada

Location

K-W Musculoskeletal Research Inc

Kitchener, Ontario, N2M 5N6, Canada

Location

Y. Liu Medicine Professional

Milton, Ontario, L9T 3Z9, Canada

Location

Credit Valley Imaging Associates

Mississauga, Ontario, L5M 2V8, Canada

Location

Oakville Rheumatology & Osteoporosis

Oakville, Ontario, L6M 4J2, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4G2, Canada

Location

Arthur Karasik Medicine Professional Corporation

Toronto, Ontario, M9C 5N2, Canada

Location

Dr. Sabeen Anwar Medicine Professional Corporation

Windsor, Ontario, N8X 1T3, Canada

Location

Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital

Montreal, Quebec, H2L 1S6, Canada

Location

Groupe de Recherche en Rhumatologie et Maladies Osseuses (GRMO)

Québec, Quebec, G1V 3M7, Canada

Location

Centre Rhumatologie de l'Est

Rimouski, Quebec, G5L 8W1, Canada

Location

Centre de Recherche Musculo-Squelettique

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Revmatolog Mudr. Sirova Klara s.r.o.

Ostrava, 701 00, Czechia

Location

Revmatologický Ústav (RÚ)

Prague, 12850, Czechia

Location

Rheumapraxis Steglitz

Berlin, 12163, Germany

Location

Immanuel Diakonie GmbH

Bernau, 16321, Germany

Location

Rheumatologisches MVZ Dresden GmbH

Dresden, 01109, Germany

Location

Asklepios Gesundheitszentrum Elmshorn

Elmshorn, 21073, Germany

Location

Rheumatologische Praxis Dr. med. Kühne

Haldensleben I, 39340, Germany

Location

Dr. med. Jörg Kaufmann

Ludwigsfelde, 14974, Germany

Location

Praxis Dr. Herbert Kellner

München, 80639, Germany

Location

MVZ für Rheumatologie Dr. Martin Welcker GmbH

Planegg, 82152, Germany

Location

Berufsausübungsgemeinschaft Martin Bohl-Bühler & Dr. med. Sabine Reckert

Potsdam, 14469, Germany

Location

Dr. med. Jochen Walter - FA für Innere Medizin Rheumatologe

Rendsburg, 24768, Germany

Location

University General Hospital of Heraklion

Heraklion, Crete, 71110, Greece

Location

Complexo Hospitalario Universitario A Coruña

A Coruña A Coruña, 15006, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, 38320, Spain

Location

Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Location

Salisbury NHS Foundation Trust - Salisbury District Hospital

Sailsbury, SP2 8BJ, United Kingdom

Location

Related Publications (1)

• Taylor PC, Christensen R, Moosavi S, Selema P, Guilatco R, Fowler H, Mueller M, Liau KF, Haraoui B. Real-life drug persistence in patients with rheumatic diseases treated with CT-P13: a prospective observational cohort study (PERSIST). Rheumatol Adv Pract. 2021 Apr 23;5(2):rkab026. doi: 10.1093/rap/rkab026. eCollection 2021.

  PMID: 34377890 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic

Interventions

CT-P13; Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Due to erroneous data transmission/ data discrepancies which occurred with use of the electronic data capture tool, data summaries only for a portion of the data for OM 9 to 19, which corresponded to visit dates in clinical database were provided.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

8007181021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: November 16, 2015
• Study Start: September 10, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); CA (17); CZ (2); BU (3); DE (10); GR (1); GB (2)