Arthritis, RheumatoidAWARENCT02728934
Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis
An observational study of Arthritis, Rheumatoid, run by Janssen Scientific Affairs, LLC at 85 sites in United States.
Trial summary
The purpose of this study is to compare the proportion of patients with an infusion reaction in Rheumatoid arthritis (RA) patients treated with Golimumab Intravenous (IV) or Infliximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Golimumab Intravenous (IV), Infliximab and Biosimilar Infliximab
- Type of treatment
- Injection or infusion
- How many people
- 1,279 participants
- Where
- 85 sitesUnited States
- Study dates
- 25 Feb 2016to 31 Jan 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with, either Golimumab IV or Infliximab.
Who may be able to join
- Patient must be a male or female 18 years of age or older as the study is intended to assess Golimumab intravenous (IV) and Infliximab in adult RA patients
- Patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
- Patient has a confirmed diagnosis of Rheumatoid arthritis (RA) and is medically eligible for treatment with Golimumab IV or Infliximab in accordance with standard of care (example, screening for tuberculosis [TB], vaccinations, etc.)
- At the time of enrollment the patient will be initiating treatment with Golimumab IV or Infliximab. The patient may or may not have previously received treatment with a biologic. Patients with previous exposure to subcutaneously administered Simponi may enroll in the study
- Patient must be willing to complete Patient reported outcomes (PRO) forms during the study and agree to return completed forms to the site if receiving an infusion of Golimumab IV or Infliximab at a location remote from the study site
Who cannot join
- Patient is less than 18 years of age
- Patient is pregnant or planning a pregnancy
- Patient is currently enrolled in an interventional study
- Patient has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days, as appropriate, before the planned first dose of Golimumab IV or Infliximab
- Patient previously received Golimumab IV if planning to receive Golimumab IV in this study or the patient previously received Infliximab if planning to receive Infliximab or BI in this study. Patient previously receive BI if planning to receive BI or Remicade in this study
- Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (example, compromise the patient's well-being) or that could prevent, limit, or confound the protocol-specified assessments
Trial locations and contacts
85 sites in 1 country.
85 sites in 1 country
United States85 sites
Study site
Amarillo, Texas
Study site
Ann Arbor, Michigan
Study site
Arlington, Virginia
Study site
Bakersfield, California
Study site
Baton Rouge, Louisiana
Study site
Beaumont, Texas
Study site
Beckley, West Virginia
Study site
Bethlehem, Pennsylvania
Study site
Birmingham, Alabama
Study site
Bowling Green, Kentucky
Study site
Brooklyn, New York
Study site
Campbell, California
Study site
Chesapeake, Virginia
Study site
Clearwater, Florida
Study site
College Station, Texas
Study site
Corpus Christi, Texas
Study site
Covina, California
Study site
Cumberland, Maryland
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Duncansville, Pennsylvania
Study site
Eagan, Minnesota
Study site
Edina, Minnesota
Study site
Edmond, Oklahoma
Study site
El Cajon, California
Study site
Freehold, New Jersey
Study site
Glendale, Arizona
Study site
Glendale, Wisconsin
Study site
Greensboro, North Carolina
Study site
Hagerstown, Maryland
Study site
Hemet, California
Study site
Houston, Texas
Study site
Huntsville, Alabama
Study site
Kennewick, Washington
Study site
Lakewood, Colorado
Study site
Lansing, Michigan
Study site
Las Vegas, Nevada
Study site
Lawrenceville, Georgia
Study site
Leland, North Carolina
Study site
Los Angeles, California
Study site
Lubbock, Texas
Study site
Mesa, Arizona
Study site
Mesquite, Texas
Study site
Monroe, Louisiana
Study site
Muncie, Indiana
Study site
Myrtle Beach, South Carolina
Study site
Nashua, New Hampshire
Study site
Nashville, Tennessee
Study site
Nassau Bay, Texas
Study site
Newport News, Virginia
Study site
Onalaska, Wisconsin
Study site
Orchard Park, New York
Study site
Palm Harbor, Florida
Study site
Peoria, Arizona
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Plano, Texas
Study site
Plantation, Florida
Study site
Prescott, Arizona
Study site
Raleigh, North Carolina
Study site
Saint Clair Shores, Michigan
Study site
San Antonio, Texas
Study site
San Marcos, Texas
Study site
Santa Cruz, California
Study site
Seattle, Washington
Study site
Shreveport, Louisiana
Study site
South Charleston, West Virginia
Study site
Springfield, Illinois
Study site
Sugar Land, Texas
Study site
Sun City, Arizona
Study site
Tamarac, Florida
Study site
The Woodlands, Texas
Study site
Thousand Oaks, California
Study site
Towson, Maryland
Study site
Tulsa, Oklahoma
Study site
Upland, California
Study site
Van Nuys, California
Study site
Venice, Florida
Study site
Voorhees Township, New Jersey
Study site
Waco, Texas
Study site
West Hills, California
Study site
Wexford, Pennsylvania
Study site
Wheaton, Maryland
Study site
Whittier, California
Study site
Winston-Salem, North Carolina
About this study
Official title: Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis
The purpose of this study is to compare the proportion of patients with an infusion reaction in Rheumatoid arthritis (RA) patients treated with Golimumab Intravenous (IV) or Infliximab.
Read the detailed description
This is a prospective, noninterventional (no treatment medication provided by the study), observational (study in which the investigators/ physicians observe the patients and measure their outcomes), multicenter (study conducted at multiple sites) study of Golimumab IV and Infliximab in RA patients. The study allows for an anticipated 2-year enrollment period and a 3-year study duration for each patient. No interventions will be given to patients as a part of this study. This study will be conducted in the US, at rheumatology-based clinical practices and will enroll adult RA patients who meet all entry criteria. The primary endpoint of this study is the proportion of patients with an infusion reaction through week 52. Patients will be enrolled in a 1:1 ratio to initiate treatment with either Golimumab IV or Infliximab. Patients' safety will be monitored throughout the study.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Golimumab Intravenous (IV), Infliximab, Biosimilar Infliximab
- Keywords
- Rheumatoid Arthritis, Golimumab, Infliximab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Golimumab Intravenous (IV)Biological
Also called Simponi Aria
This is an observational study. Patients who will receive golimumab IV will be observed for 3 years.
InfliximabBiological
Also called Remicade
This is an observational study. Patients who will receive infliximab will be observed for 3 years.
Biosimilar InfliximabBiological
Also called Inflectra
This is an observational study. New patients who will receive biosimilar infliximab will be observed for 3 years (maximum). Biosimilar Infliximab patients will be included in Exploratory analyses only and will not be included in Primary or Secondary outcome measures analyses.
| Study group | Role | What they receive |
|---|---|---|
| Golimumab Intravenous (IV) | Patients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with Golimumab IV. Receives: Biological: Golimumab Intravenous (IV) | |
| Infliximab | Patients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with Infliximab. Receives: Biological: Infliximab; Biological: Biosimilar Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With an Infusion Reaction Through Week 52
An infusion reaction is any adverse event that occurs during an infusion or within 1 hour of completion of infusion of either Golimumab IV or Infliximab. The number of patients with infusion reactions will be reported.
Measured: Up to week 52
Secondary outcomes (16)
Change from Baseline in Clinical Disease Activity Index (CDAI) Score in Bionaïve Patients at Month 6
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. The change from baseline at Month 6 in CDAI in bionaive patients will be reported.
Measured: Baseline and Month 6
Change from Baseline in CDAI Score in Bionaïve Patients at Month 12
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. The change from baseline at Month 12 in CDAI in bionaïve patients will be reported.
Measured: Baseline and Month 12
Change from Baseline in CDAI Score in Bionaïve Patients at Month 3
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. The change from baseline at Month 3 in CDAI in bionaïve patients will be reported.
Measured: Baseline and Month 3
CDAI Score in Patients with or Without Concomitant Methotrexate use
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. CDAI score in patients with or without concomitant methotrexate use, will be reported.
Measured: Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
Change from Baseline in CDAI Score in Patients with or Without Concomitant Methotrexate use
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. Change from baseline in CDAI score in patients with or without concomitant methotrexate use, will be reported.
Measured: Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
CDAI Score in Dose-escalated Patients
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. CDAI score in patients in whom dose of Remicade was escalated (increased prescribe dose or reduced dose interval, or a combination of both), will be reported.
Measured: Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
Change from Baseline in CDAI Score in Dose-escalated Patients
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. Change from baseline in CDAI score in patients in whom dose of Remicade was escalated (increased prescribe dose or reduced dose interval, or a combination of both), will be reported.
Measured: Baseline, Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. CDAI score in patients who previously administered Remicade (or other biologic[s]), will be reported.
Measured: Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
Change from Baseline in CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])
The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. Change from baseline in CDAI score in patients who previously administered Remicade (or other biologic[s]), will be reported.
Measured: Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
Number of Patients With Serious Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction
Measured: 3 years
Number of Infusions With Infusion Reactions
Measured: 3 years
Discontinuation Rates
Participants discontinuation rates for both the Simponi Aria and Remicade groups will be reported.
Measured: 3 years
Persistency of use of Treatment
Persistency of use, defined as the continuous period of time a participant receives either Simponi Aria or Remicade, will be reported.
Measured: 3 years
Number of Patients with Adverse Events (AEs) and Serious AEs
Measured: 3 years
Number of Patients With an Infusion Reaction
Measured: 3 years
Number of Patients With Severe Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction
Measured: Up to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start25 Feb 2016
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,279 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728934
- Sponsor's protocol ID
- CR108132
- Other IDs
- CNTO148ART4011
- Acronym
- AWARE
- Status last verified
- Apr 2020
- First submitted
- 31 Mar 2016
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Publications
Broadwell A, Schechtman J, Conaway D, Kivitz A, Shiff NJ, Black S, Xu S, Langholff W, Schwartzman S, Curtis JR. Effectiveness and safety of intravenous golimumab with and without concomitant methotrexate in patients with rheumatoid arthritis in the prospective, noninterventional AWARE study. BMC Rheumatol. 2023 Mar 27;7(1):5. doi: 10.1186/s41927-023-00329-8.
PubMed 36973741Bingham CO 3rd, Black S, Shiff NJ, Xu S, Langholff W, Curtis JR. Response to Treatment with Intravenous Golimumab or Infliximab in Rheumatoid Arthritis Patients: PROMIS Results from the Real-World Observational Phase 4 AWARE Study. Rheumatol Ther. 2023 Jun;10(3):659-678. doi: 10.1007/s40744-023-00533-5. Epub 2023 Feb 23.
PubMed 36820983Curtis JR, Chakravarty SD, Black S, Kafka S, Xu S, Langholff W, Parenti D, Greenspan A, Schwartzman S. Incidence of Infusion Reactions and Clinical Effectiveness of Intravenous Golimumab Versus Infliximab in Patients with Rheumatoid Arthritis: The Real-World AWARE Study. Rheumatol Ther. 2021 Dec;8(4):1551-1563. doi: 10.1007/s40744-021-00354-4. Epub 2021 Aug 20.
PubMed 34417735
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02728934
- Acronym / sponsor ID
- AWARE / CR108132
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid Arthritis, Golimumab, Infliximab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,279 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2016 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the proportion of patients with an infusion reaction in Rheumatoid arthritis (RA) patients treated with Golimumab Intravenous (IV) or Infliximab.
Detailed description
This is a prospective, noninterventional (no treatment medication provided by the study), observational (study in which the investigators/ physicians observe the patients and measure their outcomes), multicenter (study conducted at multiple sites) study of Golimumab IV and Infliximab in RA patients. The study allows for an anticipated 2-year enrollment period and a 3-year study duration for each patient. No interventions will be given to patients as a part of this study. This study will be conducted in the US, at rheumatology-based clinical practices and will enroll adult RA patients who meet all entry criteria. The primary endpoint of this study is the proportion of patients with an infusion reaction through week 52. Patients will be enrolled in a 1:1 ratio to initiate treatment with either Golimumab IV or Infliximab. Patients' safety will be monitored throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Golimumab Intravenous (IV) | – | Biological: Golimumab Intravenous (IV)Patients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with Golimumab IV. |
| Infliximab | – | Biological: Infliximab, Biological: Biosimilar InfliximabPatients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with Infliximab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with, either Golimumab IV or Infliximab.
Key inclusion criteria (5 listed)
- Patient must be a male or female 18 years of age or older as the study is intended to assess Golimumab intravenous (IV) and Infliximab in adult RA patients
- Patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
- Patient has a confirmed diagnosis of Rheumatoid arthritis (RA) and is medically eligible for treatment with Golimumab IV or Infliximab in accordance with standard of care (example, screening for tuberculosis [TB], vaccinations, etc.)
- At the time of enrollment the patient will be initiating treatment with Golimumab IV or Infliximab. The patient may or may not have previously received treatment with a biologic. Patients with previous exposure to subcutaneously administered Simponi may enroll in the study
- Patient must be willing to complete Patient reported outcomes (PRO) forms during the study and agree to return completed forms to the site if receiving an infusion of Golimumab IV or Infliximab at a location remote from the study site
Key exclusion criteria (6 listed)
- Patient is less than 18 years of age
- Patient is pregnant or planning a pregnancy
- Patient is currently enrolled in an interventional study
- Patient has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days, as appropriate, before the planned first dose of Golimumab IV or Infliximab
- Patient previously received Golimumab IV if planning to receive Golimumab IV in this study or the patient previously received Infliximab if planning to receive Infliximab or BI in this study. Patient previously receive BI if planning to receive BI or Remicade in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Golimumab Intravenous (IV)Also: Simponi AriaThis is an observational study. Patients who will receive golimumab IV will be observed for 3 years. | Biological | Golimumab Intravenous (IV) |
| InfliximabAlso: RemicadeThis is an observational study. Patients who will receive infliximab will be observed for 3 years. | Biological | Infliximab |
| Biosimilar InfliximabAlso: InflectraThis is an observational study. New patients who will receive biosimilar infliximab will be observed for 3 years (maximum). Biosimilar Infliximab patients will be included in Exploratory analyses only and will not be included in Primary or Secondary outcome measures analyses. | Biological | Infliximab |
Primary outcome
Proportion of Patients With an Infusion Reaction Through Week 52
Time frame: Up to week 52
An infusion reaction is any adverse event that occurs during an infusion or within 1 hour of completion of infusion of either Golimumab IV or Infliximab. The number of patients with infusion reactions will be reported.
16 secondary outcomes
Change from Baseline in Clinical Disease Activity Index (CDAI) Score in Bionaïve Patients at Month 6
Time frame: Baseline and Month 6
Change from Baseline in CDAI Score in Bionaïve Patients at Month 12
Time frame: Baseline and Month 12
Change from Baseline in CDAI Score in Bionaïve Patients at Month 3
Time frame: Baseline and Month 3
CDAI Score in Patients with or Without Concomitant Methotrexate use
Time frame: Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
Change from Baseline in CDAI Score in Patients with or Without Concomitant Methotrexate use
Time frame: Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
CDAI Score in Dose-escalated Patients
Time frame: Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
Change from Baseline in CDAI Score in Dose-escalated Patients
Time frame: Baseline, Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])
Time frame: Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
Change from Baseline in CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])
Time frame: Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)
Number of Patients With Serious Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction
Time frame: 3 years
Number of Infusions With Infusion Reactions
Time frame: 3 years
Discontinuation Rates
Time frame: 3 years
Persistency of use of Treatment
Time frame: 3 years
Number of Patients with Adverse Events (AEs) and Serious AEs
Time frame: 3 years
Number of Patients With an Infusion Reaction
Time frame: 3 years
Number of Patients With Severe Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction
Time frame: Up to week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Derived from this study: PubMed 36973741Broadwell A, Schechtman J, Conaway D, Kivitz A, Shiff NJ, Black S, Xu S, Langholff W, Schwartzman S, Curtis JR. Effectiveness and safety of intravenous golimumab with and without concomitant methotrexate in patients with rheumatoid arthritis in the prospective, noninterventional AWARE study. BMC Rheumatol. 2023 Mar 27;7(1):5. doi: 10.1186/s41927-023-00329-8.
- Derived from this study: PubMed 36820983Bingham CO 3rd, Black S, Shiff NJ, Xu S, Langholff W, Curtis JR. Response to Treatment with Intravenous Golimumab or Infliximab in Rheumatoid Arthritis Patients: PROMIS Results from the Real-World Observational Phase 4 AWARE Study. Rheumatol Ther. 2023 Jun;10(3):659-678. doi: 10.1007/s40744-023-00533-5. Epub 2023 Feb 23.
- Derived from this study: PubMed 34417735Curtis JR, Chakravarty SD, Black S, Kafka S, Xu S, Langholff W, Parenti D, Greenspan A, Schwartzman S. Incidence of Infusion Reactions and Clinical Effectiveness of Intravenous Golimumab Versus Infliximab in Patients with Rheumatoid Arthritis: The Real-World AWARE Study. Rheumatol Ther. 2021 Dec;8(4):1551-1563. doi: 10.1007/s40744-021-00354-4. Epub 2021 Aug 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Scientific Affairs, LLC Clinical Trial study director
Janssen Scientific Affairs, LLC
85 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Janssen Scientific Affairs, LLC at 85 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With an Infusion Reaction Through Week 52 (time frame: Up to week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02728934, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.