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non-TNFi-biologic class for Rheumatoid Arthritis

Tufts University, Boston, MA
Rheumatoid ArthritisTNFi-biologic class - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of different RA treatments in patients who have not responded to a TNFi biologic.

Eligible Conditions
  • Rheumatoid Arthritis

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

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IA-14069
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Methotrexate

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Change from baseline to 12 months

Month 12
Functional Limitation

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
MultiSpectral Imaging System
1
IA-14069
2
Methotrexate

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

non-TNFi-biologic class
1 of 4
tsDMARD class
1 of 4
TNFi-biologic class
1 of 4
targeted synthetic DMARD class
1 of 4

Active Control

924 Total Participants · 4 Treatment Groups

Primary Treatment: non-TNFi-biologic class · No Placebo Group · Phase 3

non-TNFi-biologic class
Drug
ActiveComparator Group · 1 Intervention: non-TNFi-biologic class · Intervention Types: Drug
tsDMARD class
Drug
ActiveComparator Group · 1 Intervention: tsDMARD class · Intervention Types: Drug
TNFi-biologic class
Drug
ActiveComparator Group · 1 Intervention: TNFi-biologic class · Intervention Types: Drug
targeted synthetic DMARD class
Drug
ActiveComparator Group · 1 Intervention: targeted synthetic DMARD class · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to 12 months

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,472 Previous Clinical Trials
2,245,145 Total Patients Enrolled
15 Trials studying Rheumatoid Arthritis
114,888 Patients Enrolled for Rheumatoid Arthritis
Patient-Centered Outcomes Research InstituteOTHER
507 Previous Clinical Trials
29,854,332 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
816 Patients Enrolled for Rheumatoid Arthritis
Jasvinder Singh, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
60 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have severe rheumatoid arthritis (RA) that is not responding to a TNFi-biologic after at least 3 months of treatment or you had to stop taking the medication due to side effects, regardless of how long you were on it, and your RA is still causing significant disability.

Who else is applying?

What state do they live in?
Alabama100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Alabama at Birmingham100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

How many test subjects are you taking on for this experiment?

"That is correct, the online information does state that the researchers are currently looking for individuals to take part in this trial. This specific study was posted on September 22nd 2021 and updated June 9th 2022. They are expecting a total of 924 participants from 1 location." - Anonymous Online Contributor

Unverified Answer

What are the risks associated with non-TNFi-biologic class medication?

"There is some evidence to support the efficacy of non-TNFi-biologic class drugs, as well as data from multiple rounds of testing that suggest these medications are safe. Consequently, our team has given them a score of 3." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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