A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

Study Purpose

The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of RA based on 2010 ACR/EULAR for RA for at least a 4 month duration.
  • - Moderately to severely active RA based on local standard of care.

Exclusion Criteria:

-Evidence of untreated or inadequately treated latent or active TB.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04230213
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Lithuania, Poland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Treatment Arm 1

Subcutaneous (SC) injection given every other week

Active Comparator: Treatment Arm 2

SC injection given every other week

Interventions

Drug: - PF-06410293

SC injection

Drug: - adalimumab

SC injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Medical Research, Daytona Beach, Florida

Status

Not yet recruiting

Address

International Medical Research

Daytona Beach, Florida, 32117

Graves Gilbert Clinic, Bowling Green, Kentucky

Status

Not yet recruiting

Address

Graves Gilbert Clinic

Bowling Green, Kentucky, 42101

Altoona Center for Clinical Research, Duncansville, Pennsylvania

Status

Not yet recruiting

Address

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635

Metroplex Clinical Research Center, Dallas, Texas

Status

Not yet recruiting

Address

Metroplex Clinical Research Center

Dallas, Texas, 75231

Rheumatology and Pulmonary Clinic, Beckley, West Virginia

Status

Recruiting

Address

Rheumatology and Pulmonary Clinic

Beckley, West Virginia, 25801

International Sites

Kaunas, Lithuania

Status

Not yet recruiting

Address

Hospital of Lithuanian University of Health Sciences, Kauno klinikos

Kaunas, , LT-50161

Klaipeda University Hospital, Klaipeda, Lithuania

Status

Not yet recruiting

Address

Klaipeda University Hospital

Klaipeda, , LT-92288

Pratia MCM Krakow, Krakow, Poland

Status

Not yet recruiting

Address

Pratia MCM Krakow

Krakow, , 30-510

NZOZ Lecznica MAK-MED s.c., Nadarzyn, Poland

Status

Not yet recruiting

Address

NZOZ Lecznica MAK-MED s.c.

Nadarzyn, , 05-830

Nowa Sol, Poland

Status

Not yet recruiting

Address

Twoja Przychodnia Centrum Medyczne Nowa Sol

Nowa Sol, , 67-100

Poznan, Poland

Status

Not yet recruiting

Address

Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj

Poznan, , 61-397

Nasz Lekarz Przychodnie Medyczne, Torun, Poland

Status

Not yet recruiting

Address

Nasz Lekarz Przychodnie Medyczne

Torun, , 87-100