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Methotrexate for Rheumatoid Arthritis

Aclaris Investigational Site, Brno, Czechia
Rheumatoid ArthritisMethotrexate - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, ATI-450, to see if it is better than placebo at treating RA when used with methotrexate.

Eligible Conditions
  • Rheumatoid Arthritis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Methotrexate
1
IA-14069
1
KPL-404

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: Up to 30 days after 12 weeks of treatment

Baseline to Week 12
Incidence of adverse events (AEs), serious AEs (SAEs), laboratory value abnormalities, electrocardiogram (ECG) abnormalities, vital signs abnormalities
Proportion of patients achieving ACR20 at Week 12
Proportion of patients achieving ACR50/70 at Week 12
Day 1
Trough ATI-450 and metabolite (CDD-2164) concentrations at clinic visits (trough and 2-hour post dose will be collected).
Up to 12 Weeks
FACIT-Fatigue score over time
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) score over time
HAQ-DI score over time
Health Assessment Questionnaire-Disability Index (HAQ-DI) score over time
Mean change from baseline in CDAI over time
Mean change from baseline in DAS28-CRP over time
Proportion of patients achieving ACR20/50/70 over time
Proportion of patients achieving CDAI remission (score ≤ 2.8) over time
Proportion of patients achieving DAS28-CRP low disease activity (score ≤ 3.2) over time
Proportion of patients achieving DAS28-CRP remission (score < 2.6) over time
SF-36v2 score over time
Short Form Health Survey version-2.0 (SF-36v2) score over time
Week 12
Percent change from baseline in hsCRP level over time

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Methotrexate
1
IA-14069
2
KPL-404

Side Effects for

TCZ COMBO - All Participants
11%Rheumatoid arthritis
11%Rhinitis
9%Bronchitis
9%Asthenia
8%Arthralgia
8%Headache
8%Nasopharyngitis
8%Alanine aminotransferase increased
7%Neutropenia
6%Diarrhoea
5%Insomnia
5%Abdominal pain
5%Transaminases increased
5%Hepatocellular injury
5%Back pain
4%Urinary tract infection
3%Injection site erythema
3%Ear infection
3%Pruritus
2%Nausea
2%Hypertension
1%Cataract
1%Angioedema
1%Septic shock
1%Deep vein thrombosis
1%Gastric volvulus
1%Disseminated tuberculosis
1%Cervical dysplasia
1%Intestinal ischaemia
1%Pulmonary embolism
1%Gastric ulcer
1%Meningitis tuberculous
1%Iron deficiency anaemia
1%Hypertensive crisis
1%Fall
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT02001987) in the TCZ COMBO - All Participants ARM group. Side effects include: Rheumatoid arthritis with 11%, Rhinitis with 11%, Bronchitis with 9%, Asthenia with 9%, Arthralgia with 8%.

Trial Design

3 Treatment Groups

ATI-450 50mg BID plus Methotrexate
1 of 3
ATI-450 20mg BID plus Methotrexate
1 of 3
Placebo plus Methotrexate
1 of 3

Experimental Treatment

Non-Treatment Group

240 Total Participants · 3 Treatment Groups

Primary Treatment: Methotrexate · Has Placebo Group · Phase 2

ATI-450 50mg BID plus MethotrexateExperimental Group · 3 Interventions: ATI-450 20mg oral tablet BID, ATI-450 50mg oral tablet BID, Methotrexate · Intervention Types: Drug, Drug, Drug
ATI-450 20mg BID plus MethotrexateExperimental Group · 3 Interventions: ATI-450 20mg oral tablet BID, ATI-450 50mg oral tablet BID, Methotrexate · Intervention Types: Drug, Drug, Drug
Placebo plus MethotrexatePlaceboComparator Group · 2 Interventions: Methotrexate, Placebo oral tablet · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate
2013
Completed Phase 4
~3800

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days after 12 weeks of treatment

Who is running the clinical trial?

Aclaris Therapeutics, Inc.Lead Sponsor
31 Previous Clinical Trials
4,522 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
25 Patients Enrolled for Rheumatoid Arthritis
Ajay AggarwalStudy DirectorAclaris Therapeutics, Inc.
2 Previous Clinical Trials
142 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been taking methotrexate (MTX) for at least 12 weeks and have not changed the dosage during that time.
References

Frequently Asked Questions

Are there any dangerous side effects associated with Methotrexate?

"There is some data supporting Methotrexate's safety, but none indicating its efficacy. Consequently, it received a score of 2." - Anonymous Online Contributor

Unverified Answer

How many study participants are being enrolled in this clinical trial?

"That is accurate, the clinical trial is ongoing and recruiting patients. The original posting was on February 2nd, 2022 with the most recent update occurring on August 23rd, 2022. There are 9 different recruitment sites for this study and the goal is to have 240 total participants." - Anonymous Online Contributor

Unverified Answer

Does this research include elderly participants?

"In order to be eligible for this study, patients must between 18 and 75 years old. There are 53 other trials available for minors and 347for senior citizens." - Anonymous Online Contributor

Unverified Answer

In how many different medical clinics is this clinical study being conducted today?

"Currently, this trial is taking place in 9 clinics which are situated in Mesquite, La Jolla, Duncansville and 6 other cities. If you're interested in participating, please consult the list of locations to find the one nearest you to reduce travel costs and time." - Anonymous Online Contributor

Unverified Answer

Are there any available positions for patients in this trial?

"Yes, the clinical trial is currently open and recruiting patients. According to the most recent update on 8/23/2022, they are looking for 240 participants total at 9 different locations." - Anonymous Online Contributor

Unverified Answer

How can I get involved with this research?

"This clinical trial is open to adults with rheumatoid arthritis aged 18-75. Eligible patients must be able to understand and sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved patient informed consent form prior to any study procedures, have a diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria, have active moderate to severe RA at screening, and be stable on methotrexate therapy for at least 12 weeks." - 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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