An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ALX-0061
Intervention description: Subjects received ALX-0061 150 mg s.c. injections, beginning at Week 0 and q2w thereafter, up to and including Week 102. Subjects from the preceding study ALX0061-C201 also continued their MTX treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 406.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This was a multicenter, open-label extension (OLE) Phase II study designed to evaluate the
      long-term efficacy and safety of ALX-0061 (i.e., vobarilizumab) administered subcutaneously
      (s.c.) in subjects with active rheumatoid arthritis (RA) who had completed the treatment and
      assessment period of one of the preceding Phase IIb studies with ALX-0061 (ALX0061-C201 and
      ALX0061-C202; placebo and ALX-0061 treatment arms only), and who achieved at least 20%
      improvement in swollen joint count (SJC) and/or tender joint count (TJC) (66/68 counts)
      compared to Baseline at the final visit of the preceding study (i.e., Week 24 for Study
      ALX0061-C201 and Week 12 for Study ALX0061-C202).
    

Eligibility 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.