A Trial to Evaluate the Safety and Tolerability of MT203 in Patients With Mild to Moderate Rheumatoid Arthritis (PRIORA)
This study is ongoing, but not recruiting participants.
Sponsor:
Takeda Pharma A/S
Information provided by (Responsible Party):
Takeda ( Takeda Pharma A/S )
ClinicalTrials.gov Identifier:
NCT01317797
First received: February 18, 2011
Last updated: June 11, 2013
Last verified: June 2013
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Purpose
The purpose of this trial is primarily to investigate the safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis. Furthermore, the amount of MT203 in the blood will be measured and it will be investigated how the body responds to MT203 treatment and if MT203 is effective in the treatment of rheumatoid arthritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: MT203 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase Ib Double-blind, Placebo-controlled, Randomized, Dose-escalating Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Subcutaneous Injections of MT203 in Patients With Mild to Moderate Rheumatoid Arthritis on Treatment With Methotrexate |
Resource links provided by NLM:
Further study details as provided by Takeda:
Primary Outcome Measures:
- Safety and tolerability as assessed by clinical laboratory (haematology, chemistry, coagulation, urinalysis) [ Time Frame: Average up to 113 days after first IMP (Investigational Medicinal Product) administration ] [ Designated as safety issue: Yes ]To evaluate the safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis.
- Safety and tolerability as assessed by electrocardiogram [ Time Frame: Average up to 113 days after first IMP administration ] [ Designated as safety issue: Yes ]To evaluate the safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis.
- Safety and tolerability as assessed by vital signs [ Time Frame: Average up to 113 days after first IMP administration ] [ Designated as safety issue: Yes ]To evaluate the safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis.
- Safety and tolerability as assessed by pulmonary function [ Time Frame: Average up to 113 days after first IMP administration ] [ Designated as safety issue: Yes ]To evaluate the safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis.
- Safety and tolerability as assessed by physical examination [ Time Frame: Average up to 113 days after first IMP administration ] [ Designated as safety issue: Yes ]To evaluate the safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis.
- Safety and tolerability as assessed by adverse events [ Time Frame: Average up to 113 days after first IMP administration ] [ Designated as safety issue: Yes ]To evaluate the safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis.
Secondary Outcome Measures:
- MT203 concentration in the blood (pharmacokinetics) [ Time Frame: Average up to 113 days after first IMP administration ] [ Designated as safety issue: No ]To evaluate the pharmacokinetics of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis
- GM-CSF in plasma, MT203/GM-CSF complexes in plasma, immunogenicity in blood (pharmacodynamics) [ Time Frame: Average up to 113 days after first IMP administration ] [ Designated as safety issue: No ]To evaluate the pharmacodynamics of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis
- Biomarkers in the blood (cytokines and inflammatory proteins) will be assessed exploratively [ Time Frame: Average up to 113 days after first IMP administration ] [ Designated as safety issue: No ]To evaluate the biomarkers of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis
- First signal of efficacy of repeated doses assessed by ACR and Disease Activity Score (DAS), pharmacokinetics, pharmacodynamics, and explorative biomarkers [ Time Frame: Average up to 113 days after first IMP administration ] [ Designated as safety issue: No ]To evaluate the efficacy of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis.
| Enrollment: | 24 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: MT203 |
Drug: MT203
administered three times, subcutaneous in the abdomen
|
| Placebo Comparator: Placebo |
Drug: Placebo
administered three times, subcutaneous in the abdomen
|
Detailed Description:
The trial medication will be administered at 2 dose levels as subcutaneous injections. Each patient will receive three injections in total. The trial duration consists of a screening period (28 - 2 days prior to the first injection) and a treatment and observation period (4 months). The trial requires approximately 20 visits at the study site.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Out-patients with active rheumatoid arthritis (RA), according to the ACR 1987 revised criteria, with low to moderate disease activity (DAS28-ESR ≥ 2.6 and ≤ 5.1)
- Patients must be on stable doses of methotrexate (MTX) ≥ 7.5 and ≤ 25 mg/week for at least 12 weeks before the first injection, with appropriate folic acid supplementation
- Age ≥ 18 years at Screening
- Body weight at least 50 kg at Screening; BMI: ≥ 18.0 and ≤ 30.0 kg/m2 at Screening
- Negative tuberculosis test at Screening
- Heterosexually active male and female patients of childbearing potential are obliged to follow whatever contraceptive and / or breastfeeding restrictions may be required for their concomitant medication(s), including methotrexate.
In addition, heterosexually active male and female patients of childbearing potential are required to use effective double-method contraception (one hormonal contraceptive or intrauterine device and one other additional contraceptive method) for 1 month before the first administration of the IMP, during the course of the trial, and for 6 month after the last injection of MT203.
No special requirements are made for female patients proven to be post-menopausal (at least 2 years after last menstrual period and FSH ≥ 40IU/L), surgically sterilized or hysterectomized. Likewise no special requirements for heterosexually active male who are surgical sterilized.
Pregnant or lactating female patients have to be excluded.
Exclusion Criteria:
- Participation in another clinical trial or previous dosing in this trial
- Use of specified medications within certain timeframes or use of certain comedications
- History or presence of specified diseases
- Drug abuse
- Certain laboratory parameters outside a specified range
- Donation of blood
- Relevant decrease in lung function
- Infections, frequent or chronic infections, herpes zoster
- Females: positive pregnancy test
- Presence of history of tuberculosis
- History of malignancy
Contacts and Locations More Information
No publications provided
| Responsible Party: | Takeda ( Takeda Pharma A/S ) |
| ClinicalTrials.gov Identifier: | NCT01317797 History of Changes |
| Other Study ID Numbers: | M1-1188-002-EM, 2010-018502-36, U1111-1137-3923, NL33507.058.10 |
| Study First Received: | February 18, 2011 |
| Last Updated: | June 11, 2013 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Takeda:
|
Rheumatoid Arthritis MT203 Human IgG1 monoclonal antibody GM-CSF monoclonal antibody |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013