An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02518620
• Date of registration: 06/08/2015
• Prospective Registration: No
• Primary sponsor: Ablynx
• Public title: An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis
• Scientific title: A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects With Moderate to Severe Rheumatoid Arthritis Who Have Completed One of the Preceding Phase IIb Studies With ALX-0061
• Date of first enrolment: July 2015
• Target sample size: 406
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02518620
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium, Bulgaria, Georgia, Germany, Hungary, Macedonia, The Former Yugoslav Republic of, Mexico, Moldova, Republic of, North Macedonia, Poland, Romania, Serbia, Spain

Contacts

• Name: Medical Monitor
• Affiliation: Ablynx NV

Key inclusion & exclusion criteria

Inclusion Criteria:

- Must have been eligible for one of the preceding Phase IIb studies with ALX-0061
(study ALX0061-C201 or ALX0061-C202), have been randomized to placebo or one of the
ALX-0061 arms (subjects randomized to tocilizumab [TCZ] in study ALX0061-C202 were not
eligible), and completed the entire treatment and assessment period of the preceding
studies (i.e., 24 weeks for study ALX0061-C201 and 12 weeks for study ALX0061-C202).

- Must have reached at least 20% improvement in SJC and/or TJC (66/68 counts) compared
to Week 0 at Week 24 for subjects participating in the preceding Phase IIb ALX0061
C201 study, or at Week 12 for subjects participating in the preceding Phase IIb
ALX0061-C202 study

- Female subjects of childbearing potential (excluding postmenopausal women, sterilized,
ovariectomized, and hysterectomized women) must agree to use 2 generally accepted
adequate contraceptive methods of which 1 is a barrier method (e.g., hormonal
contraception stabilized for at least 1 month [oral, patch, depot, injectable, vaginal
ring] in combination with condom by partner) or should agree upon continuous
abstinence from heterosexual contact from screening/baseline until at least 6 months
after last dosing. Male subjects must use condoms for the duration of the study and
for at least 6 months after last administration of study drug.

- Ability to comprehend and willingness to sign the informed consent form (ICF).

- An understanding of and ability and willingness to adhere to the study visit schedule
and other protocol requirements.

Exclusion Criteria:

- Received TCZ during the previous Study ALX0061-C202.

- Received any prohibited treatment during the previous Phase IIb studies (ALX0061-C201
or ALX0061-C202.

- Diagnosis of or suspicion of a serious infection (requiring parental antibiotics
and/or hospitalization) or tuberculosis during the preceding study.

- Diagnosis of malignancy or demyelinating disease during the preceding study.

- Any active or recurrent viral infection that made the subject unsuitable for the study
based on the Investigator's clinical assessment, including recurrent/disseminated
herpes zoster.

- Diagnosis of congestive heart failure class III or IV (as defined by the New York
Heart Association), unstable angina pectoris, myocardial infarction, and/or
cerebrovascular accident during the preceding study.

- Abnormality in laboratory test results observed at the Week 22 visit for subjects
participating in the preceding Phase IIb ALX0061-C201 study, or observed at the Week
10 visit for subjects participating in the preceding Phase IIb ALX0061-C202 study:

1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels = 2
times the upper limit of normal (ULN).

2. Hemoglobin levels = 85 g/L (8.5 g/dL).

3. Platelet count = 75 x 109/L (75,000 cells/mm³).

4. Absolute neutrophil count < 1.5 x 109/L.

5. Serum creatinine levels = 1.5 mg/dL (133 µmol/L).

6. Any other clinically significant abnormal laboratory result as evaluated by the
Investigator.

7. If no laboratory test results of the Week 22 Visit (for subjects participating in
the preceding ALX0061-C201 study) or the Week 10 Visit (for subjects
participating in the preceding ALX0061-C202 study) were available, then
laboratory values of tests performed between Week 22 and 24 (for study
ALX0061-C201) or Week 10 and 12 (for study ALX0061-C202) were taken into account
for the exclusion criteria a to e listed above.



Age minimum: 18 Years
Age maximum: 74 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: ALX-0061

Primary Outcome(s)

Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. [Time Frame: At Weeks 0, 12, 48, and 104]

Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR) [Time Frame: At Weeks 0, 12, 48, and 104]

Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP) [Time Frame: At Weeks 0, 12, 48, and 104]

Number and Percentage of Subjects With ACR70 Response. [Time Frame: At Weeks 0, 12, 48, and 104]

Number and Percentage of Subjects With ACR50 Response. [Time Frame: At Weeks 0, 12, 48, and 104]

ACR-N Index of Improvement [Time Frame: At Weeks 0, 12, 48, and 104]

Secondary ID(s)

ALX0061-C203

2014-003034-42

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02518620