A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease (SynAct-CS002)
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|ClinicalTrials.gov Identifier: NCT04004429|
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : May 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: 50 mg AP1189 Drug: AP1189 Drug: Placebo||Phase 2|
A multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with repeated doses of AP1189. The study population will consist of newly diagnosed subjects with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) > 22, who are to start up-titration with methotrexate.
The study will be conducted in two parts separated by an interim analysis.
Part 1: The subjects will be randomized in a 1:1:1 ratio into: .
- AP1189 dose 50 mg
- AP1189 dose 100 mg
Part 2: All subjects will be randomized into either design 1, 2 or 3 based on data from the interim analysis.
- Design 1: AP1189 dose 50 mg or placebo in a 2:1 ratio
- Design 2: AP1189 dose 100 mg or placebo in a 2:1 ratio
- Design 3: Continue with the same doses as in Part 1
The purpose of this study is to determine the safety and efficacy of 2 doses of AP1189 compared with placebo after 4 weeks of treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Multicenter, two-part, randomized, double-blind, placebo-controlled 4-week study with repeated doses of AP1189|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Multicenter, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients With Active Joint Disease|
|Actual Study Start Date :||August 26, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: 50 mg AP1189
50 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
Drug: 50 mg AP1189
50 mg AP1189 powder in bottle
Other Name: AP1189
Experimental: 100 mg AP1189
100 mg AP1189. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension, i e. the powder will be added 50 ml water.
100 mg AP1189 powder in bottle
Placebo Comparator: Placebo
Placebo. The treatment is a 4 week treatment. Each daily dose will be administered as a suspension i e. the powder will be added 50 ml water.
Placebo powder in bottle
- Change in CDAI [ Time Frame: 4 weeks ]The change in CDAI score from severe (CDAI > 22) to moderate (CDAI <= 22) after 4 weeks treatment compared to baseline.
- Swollen and tender joints [ Time Frame: 4 weeks ]Proportion of subjects achieving a reduction of more than 10 swollen and/or tender joints compared to baseline
- CDAI score [ Time Frame: 4 weeks ]Proportion of subjects achieving a change in CDAI score compared to baseline
- DAS28 score [ Time Frame: 4 weeks ]Proportion of subjects achieving a change in DAS28 compared to baseline
- HAQ-DI (Health Assessment Questionnaire-Disability Index) questionnaire [ Time Frame: 4 weeks ]Proportion of subjects achieving a change in HAQ-DI
- FACIT-Fatigue questionnaire [ Time Frame: 4 weeks ]Proportion of subjects achieving a change in FACIT-Fatigue
- ACR (American College of Rheumatology) response [ Time Frame: 4 weeks ]Proportion of subjects achieving a response assessed by ACR20, ACR50 and ACR70
- Effect of AP1189 as measured on the following biomarkers: CXCL13, IL-1β, IL-6, IL-10, and TNF-α [ Time Frame: 4 weeks ]Effect of AP1189, compared to placebo and by treatment group on inflammatory and collagen destructive biomarkers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004429
|Contact: Irene Sandholdt||+45 2015 firstname.lastname@example.org|
|Contact: Birgitte Telmer, MD||+45 2015 email@example.com|
|Aarhus, Denmark, 8200|
|Contact: Ellen-Margrethe Hauge, Proff. MD +45 2478 6025 firstname.lastname@example.org|
|Oslo, Norway, 0370|
|Contact: Espen A Haavardsholm, Consultant, PhD +47 2245 1500 Espen.Haavardsholm@diakonsyk.no|
|Principal Investigator:||Ellen-Margrethe Hauge, Professor||Aarhus Universitetshospital|
|Principal Investigator:||Espen A Haavardsholm, Concultant, PhD||Diakonhjemmet Hospital|